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    • id86
    • user_id26
    • application_id(null)
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    • total_sites4
    • abstract_of_study<p> Background</p> <div class="flex flex-grow flex-col max-w-full"> <div class="min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2" data-message-author-role="assistant" data-message-id="6bad6573-5683-44dc-898f-edbdad90c62b" dir="auto"> <div class="flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]"> <div class="markdown prose w-full break-words dark:prose-invert dark"> <p> Cancer treatment efficacy varies significantly among patients, often due to genetic differences in tumor cells. Identifying genetic markers that predict treatment response can enhance personalized medicine approaches, leading to improved outcomes and reduced adverse effects.</p> <h4> Objective</h4> <p> This study aims to investigate genetic markers that can predict the response to cancer treatments. By analyzing the genetic profiles of tumors from a diverse patient cohort, we seek to identify patterns associated with favorable or unfavorable treatment outcomes.</p> <h4> Methods</h4> <p> We will conduct a genome-wide association study (GWAS) using tumor samples from patients undergoing various cancer therapies. High-throughput sequencing technologies will be employed to identify genetic variants. Bioinformatics tools will analyze the correlation between these genetic variants and treatment responses, including chemotherapy, targeted therapy, and immunotherapy. Multivariate analysis will control for potential confounders such as age, sex, cancer type, and stage.</p> <h4> Results</h4> <p> Preliminary data suggest the presence of specific genetic markers associated with treatment efficacy and resistance. Identifying these markers will allow us to develop predictive models for clinical use.</p> <h4> Conclusion</h4> <p> Understanding genetic markers that predict cancer treatment response has the potential to revolutionize cancer care by facilitating personalized treatment plans. This study aims to contribute to the growing field of precision oncology, ultimately improving patient outcomes and quality of life.</p> <h4> Keywords</h4> <p> Cancer genomics, genetic markers, treatment response, personalized medicine, genome-wide association study, precision oncology.</p> </div> </div> </div> </div> <p>  </p>
    • study_title<p> Investigating Genetic Markers for Predicting Cancer Treatment Response</p>
    • laymans_summary<p> Cancer treatment can be highly effective for some patients but less so for others. This difference in treatment response often depends on unique genetic factors within each person's cancer cells. Our study aims to identify specific genetic markers that can predict how well a patient will respond to different cancer treatments.</p> <div class="flex flex-grow flex-col max-w-full"> <div class="min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2" data-message-author-role="assistant" data-message-id="3a341212-4d02-48e4-a41c-b522ac742f4c" dir="auto"> <div class="flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]"> <div class="markdown prose w-full break-words dark:prose-invert dark"> <p> By examining the DNA of cancer cells from a diverse group of patients, we hope to find patterns that indicate whether a particular treatment is likely to be successful. Understanding these genetic markers will help doctors choose the most effective therapy for each individual, leading to better outcomes and fewer side effects.</p> <p> Ultimately, our goal is to move towards more personalized cancer care, where treatments are tailored to the genetic makeup of each patient's cancer, improving the chances of successful treatment and recovery.</p> </div> </div> </div> </div> <p>  </p>
    • short_titleCancer Genomics
    • protocol_noECCT/24/06/02
    • reference_no(null)
    • version_no1.0
    • date_of_protocol11-06-2024
    • study_drugGenomirix
    • disease_conditionCancer
    • product_type_biologicals1
    • product_type_proteins1
    • product_type_immunologicals0
    • product_type_vaccines0
    • product_type_hormones0
    • product_type_toxoid0
    • product_type_chemical1
    • product_type_medical_device1
    • product_type_chemical_name4-(2-(4-Methylpiperazin-1-yl)ethyl)-N-(4-(trifluoromethyl)phenyl)pyridine-2-carboxamide
    • product_type_medical_device_nameGeneMark Analyzer
    • comparatorYes
    • comparator_nameOncoraGen
    • comparator_registeredYes
    • comparator_countriesUnited States Canada United Kingdom Germany France Japan Australia South Korea Brazil
    • ecct_not_applicable0
    • ecct_ref_number
    • email_addressjayoma@intellisoftkenya.com
    • applicant_covering_letter1
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    • declaration_applicantJavan Ayoma
    • declaration_date111-06-2024
    • declaration_principal_investigatorECR
    • declaration_date211-06-2024
    • placebo_presentNo
    • study_objectives<ol> <li> To evaluate the safety and efficacy of a new medication in reducing blood pressure in patients with hypertension.</li> <li> To compare the effectiveness of two different treatment regimens for managing symptoms of depression in adults.</li> <li> To assess the long-term outcomes of a surgical procedure for patients with advanced stage cancer.</li> <li> To investigate the impact of a lifestyle intervention program on weight loss and cardiovascular health in overweight individuals.</li> <li> To determine the optimal dosage of a novel drug in treating acute pain following surgery.</li> <li> To examine the effects of a dietary supplement on cognitive function in older adults with mild cognitive impairment.</li> <li> To explore the feasibility of a telemedicine intervention in improving access to mental health services for rural populations.</li> <li> To investigate the efficacy of a behavioral therapy in reducing symptoms of anxiety disorders in adolescents.</li> <li> To assess the safety and tolerability of a new vaccine candidate in preventing infections in children.</li> <li> To evaluate the impact of a physical activity intervention on quality of life and functional outcomes in patients with chronic pain conditions.</li> </ol>
    • principal_inclusion_criteria<ol> <li> Age between 18 and 65 years.</li> <li> Diagnosis of type 2 diabetes mellitus.</li> <li> Body mass index (BMI) between 25 and 40 kg/m^2.</li> <li> Histologically confirmed diagnosis of breast cancer.</li> <li> Presence of moderate to severe symptoms of depression as assessed by a standardized questionnaire.</li> <li> Documented history of hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.</li> <li> Diagnosis of Alzheimer's disease according to established clinical criteria.</li> <li> Previously untreated stage III non-small cell lung cancer.</li> <li> Willingness to comply with study procedures and follow-up visits.</li> <li> Written informed consent provided by the participant or legally authorized representative.</li> </ol>
    • principal_exclusion_criteria<ul> <li> Known allergy or hypersensitivity to the investigational drug or any of its components.</li> <li> History of significant cardiovascular disease, including myocardial infarction or stroke within the past 6 months.</li> <li> Presence of a severe psychiatric disorder that could affect the participant's ability to comply with study procedures.</li> <li> Use of concomitant medications that are contraindicated with the investigational drug.</li> <li> Pregnancy or breastfeeding.</li> <li> Active substance abuse or dependence within the past 12 months.</li> <li> Participation in another clinical trial within the past 30 days.</li> <li> Known history of human immunodeficiency virus (HIV) infection or hepatitis B or C.</li> <li> Uncontrolled hypertension, defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.</li> <li> Significant renal or hepatic impairment as determined by laboratory tests.</li> </ul>
    • primary_end_points<ol> <li> Change in mean systolic blood pressure from baseline to week 12.</li> <li> Percentage change in tumor size as assessed by imaging studies after 6 months of treatment.</li> <li> Time to recurrence of depressive symptoms as measured by a standardized depression rating scale.</li> <li> Overall survival at 2 years post-randomization.</li> <li> Proportion of participants achieving glycemic control (HbA1c < 7%) after 6 months of treatment.</li> <li> Improvement in cognitive function as measured by a validated cognitive assessment tool at week 24.</li> <li> Rate of adverse events leading to treatment discontinuation within the first 3 months of therapy.</li> <li> Change in mean pain intensity scores from baseline to week 8 as assessed by a visual analog scale.</li> <li> Proportion of participants achieving a 50% reduction in seizure frequency compared to baseline after 12 weeks of treatment.</li> <li> Change in mean forced expiratory volume in 1 second (FEV1) from baseline to week 26 in patients with chronic obstructive pulmonary disease (COPD).</li> </ol>
    • scope_diagnosis1
    • scope_prophylaxis0
    • scope_therapy0
    • scope_safety0
    • scope_efficacy1
    • scope_pharmacokinetic0
    • scope_pharmacodynamic0
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    • scope_dose_response0
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    • design_controlledNo
    • site_capacity(null)
    • staff_numbers<div class="flex-1 overflow-hidden"> <div class="react-scroll-to-bottom--css-wpwpj-79elbk h-full"> <div class="react-scroll-to-bottom--css-wpwpj-1n7m0yu"> <div class="flex flex-col text-sm"> <div class="w-full text-token-text-primary" data-scroll-anchor="true" data-testid="conversation-turn-35" dir="auto"> <div class="py-2 juice:py-[18px] px-3 text-base md:px-4 m-auto md:px-5 lg:px-1 xl:px-5"> <div class="mx-auto flex flex-1 gap-3 text-base juice:gap-4 juice:md:gap-5 juice:lg:gap-6 md:max-w-3xl lg:max-w-[40rem] xl:max-w-[48rem]"> <div class="group/conversation-turn relative flex w-full min-w-0 flex-col agent-turn"> <div class="flex-col gap-1 md:gap-3"> <div class="flex flex-grow flex-col max-w-full"> <div class="min-h-[20px] text-message flex flex-col items-start whitespace-pre-wrap break-words [.text-message+&]:mt-5 juice:w-full juice:items-end overflow-x-auto gap-2" data-message-author-role="assistant" data-message-id="99efe10e-e141-4373-acd9-b177540b4a00" dir="auto"> <div class="flex w-full flex-col gap-1 juice:empty:hidden juice:first:pt-[3px]"> <div class="markdown prose w-full break-words dark:prose-invert dark"> <h3> Site 1: Afya Medical Center</h3> <ul> <li> <strong>Capacity of Site:</strong> <ul> <li> Outpatient Clinic: 20 patients per hour</li> <li> Inpatient Beds: 50 beds</li> </ul> </li> <li> <strong>Number of Staff:</strong> 30 <ul> <li> Dr. Esther Mwangi - Medical Director - MD, MPH, 10 years of experience</li> <li> Nurse Jane Wanjiku - Head Nurse - BScN, 7 years of experience</li> <li> Pharmacist David Kimani - PharmD, 5 years of experience</li> <li> Lab Technician Mary Achieng - BSc in Medical Laboratory Science, 3 years of experience</li> <li> Study Coordinator Grace Njeri - BSc in Clinical Research, 2 years of experience</li> </ul> </li> <li> <strong>Facilities:</strong> Fully equipped outpatient clinic, laboratory, pharmacy, inpatient wards, emergency room</li> <li> <strong>Emergency Facilities:</strong> Fully equipped emergency room with resuscitation equipment and trained staff</li> <li> <strong>Other Relevant Infrastructure:</strong> Dedicated research wing for clinical trials, including separate study rooms and monitoring facilities.</li> </ul> <h3> Site 2: Upendo Hospital</h3> <ul> <li> <strong>Capacity of Site:</strong> <ul> <li> Outpatient Clinic: 25 patients per hour</li> <li> Inpatient Beds: 70 beds</li> </ul> </li> <li> <strong>Number of Staff:</strong> 40 <ul> <li> Dr. Kevin Maina - Medical Director - MBChB, MPH, 12 years of experience</li> <li> Nurse Sarah Kinya - Head Nurse - BScN, 8 years of experience</li> <li> Pharmacist James Ogutu - PharmD, 6 years of experience</li> <li> Lab Technician Mercy Wangari - BSc in Medical Laboratory Science, 4 years of experience</li> <li> Study Coordinator Peter Kamau - BSc in Clinical Research, 3 years of experience</li> </ul> </li> <li> <strong>Facilities:</strong> Comprehensive outpatient and inpatient facilities, including surgery theaters, radiology department, pharmacy, laboratory.</li> <li> <strong>Emergency Facilities:</strong> Dedicated emergency department with trauma center and intensive care unit.</li> <li> <strong>Other Relevant Infrastructure:</strong> On-site research department with dedicated study rooms and conference facilities.</li> </ul> <h3> Site 3: Tumaini Medical Center</h3> <ul> <li> <strong>Capacity of Site:</strong> <ul> <li> Outpatient Clinic: 30 patients per hour</li> <li> Inpatient Beds: 60 beds</li> </ul> </li> <li> <strong>Number of Staff:</strong> 35 <ul> <li> Dr. Faith Njoroge - Medical Director - MBChB, MPH, 11 years of experience</li> <li> Nurse Peter Otieno - Head Nurse - BScN, 9 years of experience</li> <li> Pharmacist Grace Wambui - PharmD, 7 years of experience</li> <li> Lab Technician John Mwangi - BSc in Medical Laboratory Science, 5 years of experience</li> <li> Study Coordinator Susan Auma - BSc in Clinical Research, 4 years of experience</li> </ul> </li> <li> <strong>Facilities:</strong> Modern outpatient department, fully equipped laboratory, pharmacy, comfortable inpatient wards.</li> <li> <strong>Emergency Facilities:</strong> Well-equipped emergency room with 24/7 availability.</li> <li> <strong>Other Relevant Infrastructure:</strong> Dedicated research wing with state-of-the-art equipment for clinical trials and data collection.</li> </ul> <h3> Site 4: Salama Clinic</h3> <ul> <li> <strong>Capacity of Site:</strong> <ul> <li> Outpatient Clinic: 15 patients per hour</li> <li> Inpatient Beds: 40 beds</li> </ul> </li> <li> <strong>Number of Staff:</strong> 25 <ul> <li> Dr. Grace Nyambura - Medical Director - MBChB, MPH, 9 years of experience</li> <li> Nurse David Gitau - Head Nurse - BScN, 6 years of experience</li> <li> Pharmacist Mary Njeri - PharmD, 4 years of experience</li> <li> Lab Technician Mercy Chepkoech - BSc in Medical Laboratory Science, 3 years of experience</li> <li> Study Coordinator Paul Ochieng - BSc in Clinical Research, 2 years of experience</li> </ul> </li> <li> <strong>Facilities:</strong> Well-equipped outpatient department, pharmacy, laboratory, and comfortable inpatient wards.</li> <li> <strong>Emergency Facilities:</strong> Dedicated emergency room with basic resuscitation equipment and trained staff.</li> <li> <strong>Other Relevant Infrastructure:</strong> Limited research facilities, but capable of conducting basic clinical research and data collection.</li> </ul> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <p>  </p>
    • other_details_explanation<ul> <li> <p> <strong>Population Diversity:</strong> Kenya offers a diverse population with varying genetic backgrounds and lifestyles, which may provide valuable insights into the generalizability of study findings across different populations.</p> </li> <li> <p> <strong>Access to Patients:</strong> Kenya may have a higher prevalence of the target disease or condition, providing easier access to eligible participants for the clinical trial.</p> </li> <li> <p> <strong>Infrastructure and Expertise:</strong> Kenya has established research institutions, hospitals, and clinics with experienced healthcare professionals and researchers capable of conducting high-quality clinical trials.</p> </li> <li> <p> <strong>Regulatory Environment:</strong> Kenya's regulatory framework for clinical trials may be favorable or offer expedited approval processes, making it an attractive location for conducting research.</p> </li> <li> <p> <strong>Ethical Considerations:</strong> Kenya may have specific ethical guidelines or cultural considerations that align with the study objectives, ensuring that research is conducted in an ethical and culturally sensitive manner.</p> </li> <li> <p> <strong>Cost Considerations:</strong> Conducting clinical trials in Kenya may be more cost-effective compared to the host country, due to lower operational costs and potentially faster recruitment timelines.</p> </li> </ul>
    • other_details_regulatory_notapproved<ol> <li> <p> <strong>Kenyan Pharmacy and Poisons Board (PPB)</strong></p> <ul> <li> Date of Application: March 15, 2024</li> </ul> </li> <li> <p> <strong>South African Health Products Regulatory Authority (SAHPRA)</strong></p> <ul> <li> Date of Application: April 10, 2024</li> </ul> </li> <li> <p> <strong>Uganda National Drug Authority (NDA)</strong></p> <ul> <li> Date of Application: May 5, 2024</li> </ul> </li> <li> <p> <strong>Tanzania Medicines and Medical Devices Authority (TMDA)</strong></p> <ul> <li> Date of Application: June 1, 2024</li> </ul> </li> <li> <p> <strong>Nigerian National Agency for Food and Drug Administration and Control (NAFDAC)</strong></p> <ul> <li> Date of Application: July 3, 2024</li> </ul> </li> </ol>
    • other_details_regulatory_approved<ul> <li> <p> <strong>United States Food and Drug Administration (FDA)</strong></p> <ul> <li> Date of Approval: January 20, 2024</li> <li> Number of Sites: <ul> <li> United States: 10 sites</li> </ul> </li> </ul> </li> <li> <p> <strong>European Medicines Agency (EMA)</strong></p> <ul> <li> Date of Approval: February 5, 2024</li> <li> Number of Sites: <ul> <li> United Kingdom: 5 sites</li> <li> Germany: 3 sites</li> <li> France: 2 sites</li> </ul> </li> </ul> </li> <li> <p> <strong>Canadian Health Products and Food Branch (HPFB)</strong></p> <ul> <li> Date of Approval: March 1, 2024</li> <li> Number of Sites: <ul> <li> Canada: 4 sites</li> </ul> </li> </ul> </li> <li> <p> <strong>Australian Therapeutic Goods Administration (TGA)</strong></p> <ul> <li> Date of Approval: March 15, 2024</li> <li> Number of Sites: <ul> <li> Australia: 3 sites</li> </ul> </li> </ul> </li> <li> <p> <strong>Brazilian Health Regulatory Agency (ANVISA)</strong></p> <ul> <li> Date of Approval: April 10, 2024</li> <li> Number of Sites: <ul> <li> Brazil: 2 sites</li> </ul> </li> </ul> </li> </ul>
    • other_details_regulatory_rejected<p> N/A</p>
    • other_details_regulatory_halted<p> N/A</p>
    • estimated_duration18 Months
    • design_controlled_randomised
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    • design_controlled_double_blind
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    • single_site_member_stateNo
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    • multiple_member_states4
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    • multi_country_listChina India Braizil Russia USA
    • data_monitoring_committeeYes
    • total_enrolment_per_site22500
    • total_participants_worldwide30000000
    • population_less_than_18_yearsYes
    • population_uteroNo
    • population_preterm_newbornNo
    • population_newbornNo
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    • gender_female1
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    • subjects_healthyYes
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    • subjects_women_child_bearingYes
    • subjects_women_using_contraceptionYes
    • subjects_pregnant_womenYes
    • subjects_nursing_womenYes
    • subjects_emergency_situationYes
    • subjects_incapable_consentYes
    • subjects_specifychildren aged 13-17years
    • subjects_othersNo
    • subjects_others_specify
    • investigator1_given_nameDr. Jane
    • investigator1_middle_name
    • investigator1_family_nameKamau
    • investigator1_qualificationMD, PhD
    • investigator1_professional_addressKenya Medical Research Institute (KEMRI) Clinical Research Center 123 Research Avenue Nairobi, Kenya
    • investigator1_telephone+254 123 456 789
    • investigator1_emailjkamau@kemri.go.ke
    • organisations_transferred_No
    • number_participants45000
    • notification<p> N/A</p>
    • approval_date21-06-2024
    • submitted1
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    • date_submitted11-06-2024
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    • ecitizen_invoice304493
    • modified2024-06-21 06:55:17
    • created2024-06-11 03:54:24
  • User(array)
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    • confirm_passwordee68d9627812445cb0ccfd02e319d77ad0f9f4c9
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    • county_id47
    • country_id115
    • group_id5
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    • forgot_password(null)
    • is_active1
    • deactivated0
    • created2024-01-17 15:58:25
    • modified2024-05-21 07:37:41
  • TrialStatus(array)
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      • emailjayoma@intellisoftkenya.com
      • created2024-06-11 03:54:24
      • modified2024-06-11 09:01:24
  • ApplicationStage(array)
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      • commentManager final decision
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      • created2024-06-11 09:01:24
      • modified2024-06-11 09:01:24
    • 1(array)
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      • created2024-06-17 13:58:13
      • modified2024-06-17 13:58:13
    • 2(array)
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      • statusComplete
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      • end_date2024-06-17
      • created2024-06-17 13:58:13
      • modified2024-06-17 13:58:13
    • 3(array)
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      • created2024-06-17 13:58:13
      • modified2024-06-17 13:58:13
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      • created2024-06-17 13:58:13
      • modified2024-06-17 13:58:13
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      • created2024-06-17 13:58:13
      • modified2024-06-17 13:58:13
    • 6(array)
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      • statusCurrent
      • commentManager approve
      • end_date2025-06-17
      • created2024-06-17 13:58:13
      • modified2024-06-17 13:58:13
  • Pharmacist(array)
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      • premise_nameJohnson's Pharmacy
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      • professional_address456 Main Street, Cityville, State, ZIP
      • valid_year2024
      • mobile+1 (555) 987-6543
      • telephone +1 (555) 123-4567
      • emailsarah.johnson@johnsonspharmacy.com
      • created2024-06-11 04:05:15
      • modified2024-06-11 09:01:24
  • EthicalCommittee(array)
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      • submission_date21-05-2024
      • erc_numberREF/GEN/0020
      • initial_approval29-05-2024
      • created2024-06-11 04:05:15
      • modified2024-06-11 09:01:24
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      • created2024-06-11 04:05:15
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  • SiteDetail(array)
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      • site_name Afya Medical Center
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      • contact_detailsTelephone Number: +254 701 234 567 P.O. Box: 10100-12345, Nairobi, Kenya
      • contact_person Dr. Esther Mwangi
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      • created2024-06-11 04:05:15
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    • 1(array)
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      • site_nameUpendo Hospital
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      • contact_detailsTelephone Number: +254 702 345 678 P.O. Box: 80100-45678, Mombasa, Kenya
      • contact_personMr. Kevin Maina
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      • created2024-06-11 04:26:59
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    • 2(array)
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      • site_nameTumaini Medical Center
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      • contact_detailsTelephone Number: +254 703 456 789 P.O. Box: 40100-78901, Kisumu, Kenya
      • contact_personDr. Faith Njoroge
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    • 3(array)
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      • site_nameSalama Clinic
      • physical_address101 Jibu Avenue, Nakuru, Kenya
      • contact_detailsTelephone Number: +254 704 567 890 P.O. Box: 20100-10101, Nakuru, Kenya
      • contact_personMs. Grace Nyambura
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  • Sponsor(array)
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      • sponsorGenoPharmaceuticals Inc.
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      • telephone_number+1 (800) 555-1234
      • fax_number+1 (800) 555-5678
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      • email_addressinfo@genopharmaceuticals.com
      • created2024-06-11 04:05:15
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      • e2b_content<?xml version="1.0" encoding="utf-8"?> <MCCI_IN200100UV01 ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3 http://eudravigilance.ema.europa.eu/XSD/multicacheschemas/MCCI_IN200100UV01.xsd" xmlns="urn:hl7-org:v3" xmlns:fo="http://www.w3.org/1999/XSL/Format" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:mif="urn:hl7-org:v3/mif"> <!--N.1.2: Batch Number--> <id extension="11917722_8P1" root="2.16.840.1.113883.3.989.2.1.3.22" /> <!--N.1.5: Date of Batch Transmission--> <creationTime value="20240111170408+0000" /> <responseModeCode code="D" /> <interactionId root="2.16.840.1.113883.1.6" extension="MCCI_IN200100UV01" /> <!--N.1.1: Type of Messages in Batch--> <name code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.1" codeSystemVersion="2.0" /> <!--N.2.r: ICH ICSR MESSAGE Header - (1)--> <PORR_IN049016UV> <!--N.2.r.1: Message Identifier--> <id extension="KE-BAYER-2024A003770" root="2.16.840.1.113883.3.989.2.1.3.1" /> <!--N.2.r.4: Date of Message Creation--> <creationTime value="20240111170407+0000" /> <interactionId root="2.16.840.1.113883.1.6" extension="PORR_IN049016UV" /> <processingCode code="P" /> <processingModeCode code="T" /> <acceptAckCode code="AL" /> <!--N.2.r.3: Message Receiver Identifier--> <receiver typeCode="RCV"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="MOHKE" root="2.16.840.1.113883.3.989.2.1.3.12" /> </device> </receiver> <!--N.2.r.2: Message Sender Identifier--> <sender typeCode="SND"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="BAYER" root="2.16.840.1.113883.3.989.2.1.3.11" /> </device> </sender> <controlActProcess classCode="CACT" moodCode="EVN"> <code code="PORR_TE049016UV" codeSystem="2.16.840.1.113883.1.18" /> <!--C.1.2: Date of Creation--> <effectiveTime value="20240111170407+0000" /> <!--C.1: Identification of the Case Safety Report --> <subject typeCode="SUBJ"> <investigationEvent classCode="INVSTG" moodCode="EVN"> <!--C.1.1: Sender's (case) Safety Report Unique Identifier --> <id root="2.16.840.1.113883.3.989.2.1.3.1" extension="KE-BAYER-2024A003770" /> <!--C.1.8.1: Worldwide Unique Case Identification Number --> <id root="2.16.840.1.113883.3.989.2.1.3.2" extension="KE-BAYER-2024A003770" /> <!--H.1: Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information --> <code code="PAT_ADV_EVNT" codeSystem="2.16.840.1.113883.5.4" /> <text></text> <statusCode code="active" /> <!--C.1.4: Date Report Was First Received from Source --> <effectiveTime> <low value="20240108" /> </effectiveTime> <!--C.1.5: Date of receipt of the most recent information for this report --> <availabilityTime value="20240108" /> <!--D: Patient Characteristics--> <component typeCode="COMP"> <adverseEventAssessment classCode="INVSTG" moodCode="EVN"> <subject1 typeCode="SBJ"> <primaryRole classCode="INVSBJ"> <player1 classCode="PSN" determinerCode="INSTANCE"> <!--D.1: Patient (name or initials)--> <name>IK</name> <!--D.5: Patient Sex--> <administrativeGenderCode code="2" codeSystem="1.0.5218" /> </player1> <!--china extention start--> <!--china extention end--> <subjectOf2 typeCode="SBJ"> <organizer classCode="CATEGORY" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="2.0" /> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - 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(4)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10027951" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (5)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10005265" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (6)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10059296" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (7)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10000081" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> </organizer> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (1)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202311" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10046784" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">Fibroids growth was found to have doubled</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (2)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202311" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10033514" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">my periods are very painful</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (3)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202311" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10036867" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">prolonged and heavy periods</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (4)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202307" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10084345" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">Drug prescribed for uterine fibroids</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (5)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202307" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10080418" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">Drug prescribed for uterine fibroids</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <subjectOf2 typeCode="SBJ"> <organizer classCode="CATEGORY" moodCode="EVN"> <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="2.0" /> <!--G.k: DRUG(S) INFORMATION - (1)--> <component typeCode="COMP"> <substanceAdministration moodCode="EVN" classCode="SBADM"> <!--G.k[GID]: Drug UUID--> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> <consumable typeCode="CSM"> <instanceOfKind classCode="INST"> <kindOfProduct classCode="MMAT" determinerCode="KIND"> <!--G.k.2.2: Medicinal Product Name as Reported by the Primary Source--> <name>Visanne</name> <asManufacturedProduct classCode="MANU"> <!--G.k.3: Holder and Authorisation / Application Number of Drug --> <subjectOf typeCode="SBJ"> <approval classCode="CNTRCT" moodCode="EVN"> <!--G.k.3.1: Authorisation / Application Number--> <id extension="H2014/CTD1052/019" root="2.16.840.1.113883.3.989.2.1.3.4" /> <holder typeCode="HLD"> <role classCode="HLD"> <!--G.k.3.3: Name of Holder / Applicant--> <playingOrganization classCode="ORG" determinerCode="INSTANCE"> <name>Bayer AG</name> </playingOrganization> </role> </holder> <author typeCode="AUT"> <territorialAuthority classCode="TERR"> <territory classCode="NAT" determinerCode="INSTANCE"> <!--G.k.3.2: Country of Authorisation / Application--> <code codeSystem="1.0.3166.1.2.2" code="KE" /> </territory> </territorialAuthority> </author> </approval> </subjectOf> </asManufacturedProduct> <!--G.k.2.3.r: Substance / Specified Substance Identifier and Strength - (1)--> <ingredient classCode="ACTI"> <quantity> <!--G.k.2.3.r.3a: Strength (number)--> <!--G.k.2.3.r.3b: Strength (unit)--> <numerator value="2" unit="mg" /> <denominator value="1" /> </quantity> <ingredientSubstance classCode="MMAT" determinerCode="KIND"> <!--G.k.2.3.r.2a: Substance / Specified Substance TermID Version Date / Number --> <!--G.k.2.3.r.2b: Substance / Specified Substance TermID --> <!--G.k.2.3.r.1: Substance / Specified Substance Name--> <name>DIENOGEST</name> </ingredientSubstance> </ingredient> </kindOfProduct> <!--G.k.2.4: Identification of the Country Where the Drug Was Obtained--> <subjectOf typeCode="SBJ"> <productEvent classCode="ACT" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.18" codeSystemVersion="2.0" /> <performer typeCode="PRF"> <assignedEntity classCode="ASSIGNED"> <representedOrganization classCode="ORG" determinerCode="INSTANCE"> <addr> <country>KE</country> </addr> </representedOrganization> </assignedEntity> </performer> </productEvent> </subjectOf> </instanceOfKind> </consumable> <!--G.k.4.r: Dosage and Relevant Information - (1)--> <outboundRelationship2 typeCode="COMP"> <substanceAdministration classCode="SBADM" moodCode="EVN"> <!--G.k.4.r.8: Dosage Text--> <text>UNK, QD</text> <!--G.k.4.r.4: Date and Time of Start of Drug--> <effectiveTime xsi:type="SXPR_TS"> <comp xsi:type="PIVL_TS"> <!--G.k.4.r.2: Number of Units in the Interval --> <!--G.k.4.r.3: Definition of the Time Interval Unit --> <period value="1" unit="d" /> </comp> <comp xsi:type="IVL_TS" operator="A"> <low value="202307" /> </comp> </effectiveTime> <consumable typeCode="CSM"> <instanceOfKind classCode="INST"> <productInstanceInstance classCode="MMAT" determinerCode="INSTANCE"> <id nullFlavor="NI" /> <!--G.k.4.r.7: Batch / Lot Number--> <lotNumberText nullFlavor="UNK" /> </productInstanceInstance> <kindOfProduct classCode="MMAT" determinerCode="KIND"> <!--G.k.4.r.9.1: Pharmaceutical form (Dosage form)--> <!--G.k.4.r.9.2a: Pharmaceutical Dose Form TermID Version Date / Number --> <!--G.k.4.r.9.2b: Pharmaceutical Dose Form TermID --> <formCode code="PDF-10219000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemVersion="1"> <originalText>Tablet</originalText> </formCode> </kindOfProduct> </instanceOfKind> </consumable> </substanceAdministration> </outboundRelationship2> <!--china extention start--> <!--china extention end--> <!--G.k.7.r: Indication for Use in Case - (1)--> <inboundRelationship typeCode="RSON"> <observation moodCode="EVN" classCode="OBS"> <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.7.r.2a: MedDRA Version for Indication--> <!--G.k.7.r.2b: Indication (MedDRA code)--> <!--G.k.7.r.1: Indication as Reported by the Primary Source--> <value xsi:type="CE" code="10046784" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="26.1"> <originalText>Uterine fibroids</originalText> </value> <performer typeCode="PRF"> <assignedEntity classCode="ASSIGNED"> <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" codeSystemVersion="2.0" displayName="sourceReporter" /> </assignedEntity> </performer> <outboundRelationship1 typeCode="REFR"> <!--G.k[GID]: Drug UUID--> <actReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </actReference> </outboundRelationship1> </observation> </inboundRelationship> </substanceAdministration> </component> </organizer> </subjectOf2> </primaryRole> </subject1> <!--G.k.1: Characterization of Drug Role--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="20" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.13" codeSystemVersion="2.0" /> <!--G.k[GID]: Drug UUID--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (1)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (2)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="2" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (3)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (4)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (5)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (6)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (7)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (8)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (9)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (10)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (1)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">not reported</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (2)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">unrelated</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (3)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" />outboundRelationship2 <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (4)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (5)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (6)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (7)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">not reported</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (8)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (9)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">not reported</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (10)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> </adverseEventAssessment> </component> <!--C.1.6.1: Are Additional Documents Available? --> <component typeCode="COMP"> <observationEvent classCode="OBS" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observationEvent> </component> <!--C.1.7: Does This Case Fulfil the Local Criteria for an Expedited Report?--> <component typeCode="COMP"> <observationEvent classCode="OBS" moodCode="EVN"> <code code="23" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="true" /> </observationEvent> </component> <!--C.1.8.2: First Sender of This Case --> <outboundRelationship typeCode="SPRT"> <relatedInvestigation classCode="INVSTG" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" codeSystemVersion="2.0" /> <subjectOf2 typeCode="SUBJ"> <controlActEvent classCode="CACT" moodCode="EVN"> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.3" codeSystemVersion="2.0" /> </assignedEntity> </author> </controlActEvent> </subjectOf2> </relatedInvestigation> </outboundRelationship> <!--C.2.r: Primary Source(s) of Information - (1)--> <outboundRelationship typeCode="SPRT"> <!--C.2.r.5: Primary Source for Regulatory Purposes--> <priorityNumber value="1" /> <relatedInvestigation classCode="INVSTG" moodCode="EVN"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" codeSystemVersion="2.0" /> <subjectOf2 typeCode="SUBJ"> <controlActEvent classCode="CACT" moodCode="EVN"> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <addr> <!--C.2.r.2.5: Reporter's State or Province--> <state nullFlavor="MSK" /> </addr> <assignedPerson classCode="PSN" determinerCode="INSTANCE"> <name> <!--C.2.r.1.2: Reporter's Given Name--> <given nullFlavor="MSK" /> <!--C.2.r.1.4: Reporter's Family Name--> <family nullFlavor="MSK" /> </name> <!--C.2.r.4: Qualification--> <asQualifiedEntity classCode="QUAL"> <code code="5" codeSystem="2.16.840.1.113883.3.989.2.1.1.6" codeSystemVersion="2.0" /> </asQualifiedEntity> <!--C.2.r.3: Reporter's Country Code--> <asLocatedEntity classCode="LOCE"> <location determinerCode="INSTANCE" classCode="COUNTRY"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </location> </asLocatedEntity> </assignedPerson> </assignedEntity> </author> </controlActEvent> </subjectOf2> </relatedInvestigation> </outboundRelationship> <!--C.3: Information on Sender of Case Safety Report--> <subjectOf1 typeCode="SUBJ"> <controlActEvent classCode="CACT" moodCode="EVN"> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--C.3.1: Sender Type--> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.7" codeSystemVersion="2.0" /> <addr> <!--C.3.4.1: Sender's Street Address--> <streetAddressLine>GLOBAL PHARMACOVIGILANCE MUELLERSTRASSE 178</streetAddressLine> <!--C.3.4.2: Sender's City--> <city>Berlin</city> </addr> <assignedPerson classCode="PSN" determinerCode="INSTANCE"> <name /> <!--C.3.4.5: Sender's Country Code--> <asLocatedEntity classCode="LOCE"> <location classCode="COUNTRY" determinerCode="INSTANCE"> <code code="DE" codeSystem="1.0.3166.1.2.2" /> </location> </asLocatedEntity> </assignedPerson> <representedOrganization classCode="ORG" determinerCode="INSTANCE"> <!--C.3.3.1: Sender's Department--> <name>GLOBAL PHARMACOVIGILANCE</name> <assignedEntity classCode="ASSIGNED"> <representedOrganization classCode="ORG" determinerCode="INSTANCE"> <!--C.3.2: Sender's Organization --> <name>Bayer AG</name> </representedOrganization> </assignedEntity> </representedOrganization> </assignedEntity> </author> </controlActEvent> </subjectOf1> <!--C.1.3: Type of Report --> <subjectOf2 typeCode="SUBJ"> <investigationCharacteristic classCode="OBS" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" codeSystemVersion="1.0" /> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.2" codeSystemVersion="2.0" /> </investigationCharacteristic> </subjectOf2> <!--C.1.9.1: Other Case Identifiers in Previous Transmissions --> <subjectOf2 typeCode="SUBJ"> <investigationCharacteristic classCode="OBS" moodCode="EVN"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" codeSystemVersion="1.0" /> <value xsi:type="BL" nullFlavor="NI" /> </investigationCharacteristic> </subjectOf2> </investigationEvent> </subject> </controlActProcess> </PORR_IN049016UV> <!--N.1.4: Batch Receiver Identifier--> <receiver typeCode="RCV"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="MOHKE" root="2.16.840.1.113883.3.989.2.1.3.14" /> </device> </receiver> <!--N.1.3: Batch Sender Identifier--> <sender typeCode="SND"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="BAYER" root="2.16.840.1.113883.3.989.2.1.3.13" /> </device> </sender> </MCCI_IN200100UV01>
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      • created2024-06-17 13:47:59
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      • e2b_content<?xml version="1.0" encoding="utf-8"?> <MCCI_IN200100UV01 ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3 http://eudravigilance.ema.europa.eu/XSD/multicacheschemas/MCCI_IN200100UV01.xsd" xmlns="urn:hl7-org:v3" xmlns:fo="http://www.w3.org/1999/XSL/Format" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:mif="urn:hl7-org:v3/mif"> <!--N.1.2: Batch Number--> <id extension="11917722_8P1" root="2.16.840.1.113883.3.989.2.1.3.22" /> <!--N.1.5: Date of Batch Transmission--> <creationTime value="20240111170408+0000" /> <responseModeCode code="D" /> <interactionId root="2.16.840.1.113883.1.6" extension="MCCI_IN200100UV01" /> <!--N.1.1: Type of Messages in Batch--> <name code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.1" codeSystemVersion="2.0" /> <!--N.2.r: ICH ICSR MESSAGE Header - (1)--> <PORR_IN049016UV> <!--N.2.r.1: Message Identifier--> <id extension="KE-BAYER-2024A003770" root="2.16.840.1.113883.3.989.2.1.3.1" /> <!--N.2.r.4: Date of Message Creation--> <creationTime value="20240111170407+0000" /> <interactionId root="2.16.840.1.113883.1.6" extension="PORR_IN049016UV" /> <processingCode code="P" /> <processingModeCode code="T" /> <acceptAckCode code="AL" /> <!--N.2.r.3: Message Receiver Identifier--> <receiver typeCode="RCV"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="MOHKE" root="2.16.840.1.113883.3.989.2.1.3.12" /> </device> </receiver> <!--N.2.r.2: Message Sender Identifier--> <sender typeCode="SND"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="BAYER" root="2.16.840.1.113883.3.989.2.1.3.11" /> </device> </sender> <controlActProcess classCode="CACT" moodCode="EVN"> <code code="PORR_TE049016UV" codeSystem="2.16.840.1.113883.1.18" /> <!--C.1.2: Date of Creation--> <effectiveTime value="20240111170407+0000" /> <!--C.1: Identification of the Case Safety Report --> <subject typeCode="SUBJ"> <investigationEvent classCode="INVSTG" moodCode="EVN"> <!--C.1.1: Sender's (case) Safety Report Unique Identifier --> <id root="2.16.840.1.113883.3.989.2.1.3.1" extension="KE-BAYER-2024A003770" /> <!--C.1.8.1: Worldwide Unique Case Identification Number --> <id root="2.16.840.1.113883.3.989.2.1.3.2" extension="KE-BAYER-2024A003770" /> <!--H.1: Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information --> <code code="PAT_ADV_EVNT" codeSystem="2.16.840.1.113883.5.4" /> <text></text> <statusCode code="active" /> <!--C.1.4: Date Report Was First Received from Source --> <effectiveTime> <low value="20240108" /> </effectiveTime> <!--C.1.5: Date of receipt of the most recent information for this report --> <availabilityTime value="20240108" /> <!--D: Patient Characteristics--> <component typeCode="COMP"> <adverseEventAssessment classCode="INVSTG" moodCode="EVN"> <subject1 typeCode="SBJ"> <primaryRole classCode="INVSBJ"> <player1 classCode="PSN" determinerCode="INSTANCE"> <!--D.1: Patient (name or initials)--> <name>IK</name> <!--D.5: Patient Sex--> <administrativeGenderCode code="2" codeSystem="1.0.5218" /> </player1> <!--china extention start--> <!--china extention end--> <subjectOf2 typeCode="SBJ"> <organizer classCode="CATEGORY" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="2.0" /> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (1)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10046784" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> <effectiveTime xsi:type="IVL_TS"> <!--D.7.1.r.2: Start Date--> <low value="2020" /> </effectiveTime> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (2)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10028634" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (3)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10024492" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (4)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10027951" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (5)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10005265" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (6)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10059296" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> <!--D.7.1.r: Relevant Medical History and Concurrent Conditions (not including reaction / event) - (7)--> <component typeCode="COMP"> <observation moodCode="EVN" classCode="OBS"> <!--D.7.1.r.1a: MedDRA Version for Medical History--> <!--D.7.1.r.1b: Medical History (disease / surgical procedure / etc.) (MedDRA code)--> <code code="10000081" codeSystemVersion="26.1" codeSystem="2.16.840.1.113883.6.163" /> </observation> </component> </organizer> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (1)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202311" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10046784" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">Fibroids growth was found to have doubled</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (2)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202311" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10033514" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">my periods are very painful</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (3)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202311" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10036867" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">prolonged and heavy periods</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (4)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202307" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10084345" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">Drug prescribed for uterine fibroids</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <!--E.i: REACTION(S)/EVENT(S) - (5)--> <subjectOf2 typeCode="SBJ"> <observation moodCode="EVN" classCode="OBS"> <!--Reaction/event [reaction/event reference ID]--> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <effectiveTime xsi:type="IVL_TS"> <!--E.i.4: Date of start of reaction/event--> <low value="202307" /> </effectiveTime> <!--E.i.2.1a: MedDRA Version for Reaction / Event--> <!--E.i.2.1b: Reaction / Event (MedDRA code)--> <value xsi:type="CE" codeSystem="2.16.840.1.113883.6.163" code="10080418" codeSystemVersion="26.1" /> <!-- E.i.9: Identification of the Country Where the Reaction / Event Occurred --> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </locatedPlace> </locatedEntity> </location> <!-- E.i.1.2: Reaction / Event as Reported by the Primary Source for Translation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="ED">Drug prescribed for uterine fibroids</value> </observation> </outboundRelationship2> <!--E.i.3.2a: Results in Death --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2b: Life Threatening --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2c: Caused / Prolonged Hospitalisation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2d: Disabling / Incapacitating --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2e: Congenital Anomaly / Birth Defect --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.3.2f: Other Medically Important Condition --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" nullFlavor="NI" /> </observation> </outboundRelationship2> <!--E.i.7: Outcome of Reaction / Event at the Time of Last Observation --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="0" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="2.0" /> </observation> </outboundRelationship2> <!--E.i.8: Medical Confirmation by Healthcare Professional --> <outboundRelationship2 typeCode="PERT"> <observation moodCode="EVN" classCode="OBS"> <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observation> </outboundRelationship2> </observation> </subjectOf2> <subjectOf2 typeCode="SBJ"> <organizer classCode="CATEGORY" moodCode="EVN"> <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="2.0" /> <!--G.k: DRUG(S) INFORMATION - (1)--> <component typeCode="COMP"> <substanceAdministration moodCode="EVN" classCode="SBADM"> <!--G.k[GID]: Drug UUID--> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> <consumable typeCode="CSM"> <instanceOfKind classCode="INST"> <kindOfProduct classCode="MMAT" determinerCode="KIND"> <!--G.k.2.2: Medicinal Product Name as Reported by the Primary Source--> <name>Visanne</name> <asManufacturedProduct classCode="MANU"> <!--G.k.3: Holder and Authorisation / Application Number of Drug --> <subjectOf typeCode="SBJ"> <approval classCode="CNTRCT" moodCode="EVN"> <!--G.k.3.1: Authorisation / Application Number--> <id extension="H2014/CTD1052/019" root="2.16.840.1.113883.3.989.2.1.3.4" /> <holder typeCode="HLD"> <role classCode="HLD"> <!--G.k.3.3: Name of Holder / Applicant--> <playingOrganization classCode="ORG" determinerCode="INSTANCE"> <name>Bayer AG</name> </playingOrganization> </role> </holder> <author typeCode="AUT"> <territorialAuthority classCode="TERR"> <territory classCode="NAT" determinerCode="INSTANCE"> <!--G.k.3.2: Country of Authorisation / Application--> <code codeSystem="1.0.3166.1.2.2" code="KE" /> </territory> </territorialAuthority> </author> </approval> </subjectOf> </asManufacturedProduct> <!--G.k.2.3.r: Substance / Specified Substance Identifier and Strength - (1)--> <ingredient classCode="ACTI"> <quantity> <!--G.k.2.3.r.3a: Strength (number)--> <!--G.k.2.3.r.3b: Strength (unit)--> <numerator value="2" unit="mg" /> <denominator value="1" /> </quantity> <ingredientSubstance classCode="MMAT" determinerCode="KIND"> <!--G.k.2.3.r.2a: Substance / Specified Substance TermID Version Date / Number --> <!--G.k.2.3.r.2b: Substance / Specified Substance TermID --> <!--G.k.2.3.r.1: Substance / Specified Substance Name--> <name>DIENOGEST</name> </ingredientSubstance> </ingredient> </kindOfProduct> <!--G.k.2.4: Identification of the Country Where the Drug Was Obtained--> <subjectOf typeCode="SBJ"> <productEvent classCode="ACT" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.18" codeSystemVersion="2.0" /> <performer typeCode="PRF"> <assignedEntity classCode="ASSIGNED"> <representedOrganization classCode="ORG" determinerCode="INSTANCE"> <addr> <country>KE</country> </addr> </representedOrganization> </assignedEntity> </performer> </productEvent> </subjectOf> </instanceOfKind> </consumable> <!--G.k.4.r: Dosage and Relevant Information - (1)--> <outboundRelationship2 typeCode="COMP"> <substanceAdministration classCode="SBADM" moodCode="EVN"> <!--G.k.4.r.8: Dosage Text--> <text>UNK, QD</text> <!--G.k.4.r.4: Date and Time of Start of Drug--> <effectiveTime xsi:type="SXPR_TS"> <comp xsi:type="PIVL_TS"> <!--G.k.4.r.2: Number of Units in the Interval --> <!--G.k.4.r.3: Definition of the Time Interval Unit --> <period value="1" unit="d" /> </comp> <comp xsi:type="IVL_TS" operator="A"> <low value="202307" /> </comp> </effectiveTime> <consumable typeCode="CSM"> <instanceOfKind classCode="INST"> <productInstanceInstance classCode="MMAT" determinerCode="INSTANCE"> <id nullFlavor="NI" /> <!--G.k.4.r.7: Batch / Lot Number--> <lotNumberText nullFlavor="UNK" /> </productInstanceInstance> <kindOfProduct classCode="MMAT" determinerCode="KIND"> <!--G.k.4.r.9.1: Pharmaceutical form (Dosage form)--> <!--G.k.4.r.9.2a: Pharmaceutical Dose Form TermID Version Date / Number --> <!--G.k.4.r.9.2b: Pharmaceutical Dose Form TermID --> <formCode code="PDF-10219000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemVersion="1"> <originalText>Tablet</originalText> </formCode> </kindOfProduct> </instanceOfKind> </consumable> </substanceAdministration> </outboundRelationship2> <!--china extention start--> <!--china extention end--> <!--G.k.7.r: Indication for Use in Case - (1)--> <inboundRelationship typeCode="RSON"> <observation moodCode="EVN" classCode="OBS"> <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.7.r.2a: MedDRA Version for Indication--> <!--G.k.7.r.2b: Indication (MedDRA code)--> <!--G.k.7.r.1: Indication as Reported by the Primary Source--> <value xsi:type="CE" code="10046784" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="26.1"> <originalText>Uterine fibroids</originalText> </value> <performer typeCode="PRF"> <assignedEntity classCode="ASSIGNED"> <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" codeSystemVersion="2.0" displayName="sourceReporter" /> </assignedEntity> </performer> <outboundRelationship1 typeCode="REFR"> <!--G.k[GID]: Drug UUID--> <actReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </actReference> </outboundRelationship1> </observation> </inboundRelationship> </substanceAdministration> </component> </organizer> </subjectOf2> </primaryRole> </subject1> <!--G.k.1: Characterization of Drug Role--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="20" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.13" codeSystemVersion="2.0" /> <!--G.k[GID]: Drug UUID--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (1)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (2)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="2" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (3)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (4)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (5)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (6)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (7)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (8)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (9)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="6" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--EU Reference instance - EU Causality assessment - (10)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3.EU.1: Result of Assessment - captured in the code field--> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.3" codeSystemVersion="1.0" /> <!--G.k.9.i.2.r.2.EU.1: EU Method of assessment - captured in the code field--> <methodCode code="1" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.2" codeSystemVersion="1.0" /> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--G.k.9.i.2.r.1.EU.1: EU Source of assessment - captured in the code field--> <code code="4" codeSystem="2.16.840.1.113883.3.989.5.1.1.5.4" codeSystemVersion="1.0" /> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (1)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">not reported</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (2)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">unrelated</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0b-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (3)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" />outboundRelationship2 <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (4)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c07-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (5)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (6)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c08-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (7)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">not reported</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (8)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c09-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (9)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">not reported</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PRIMARY SOURCE REPORTER</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> <!--G.k.9.i.2.r: Relatedness of Drug to Reaction(s) / Event(s) - (10)--> <component typeCode="COMP"> <causalityAssessment classCode="OBS" moodCode="EVN"> <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <!--G.k.9.i.2.r.3: Result of Assessment--> <value xsi:type="ST">related</value> <!--G.k.9.i.2.r.2: Method of Assessment--> <methodCode> <originalText>Global Introspection</originalText> </methodCode> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code> <!--G.k.9.i.2.r.1: Source of Assessment--> <originalText>PHARMACEUTICAL COMPANY</originalText> </code> </assignedEntity> </author> <!--G.k.9.i.1: Reaction(s) / Event(s) Assessed--> <subject1 typeCode="SUBJ"> <adverseEffectReference classCode="OBS" moodCode="EVN"> <id root="0eaf867a-6c0a-df9e-e063-b5791e0a2df1" /> </adverseEffectReference> </subject1> <!--Reference to Drug--> <subject2 typeCode="SUBJ"> <productUseReference classCode="SBADM" moodCode="EVN"> <id root="0eaf867a-6c0c-df9e-e063-b5791e0a2df1" /> </productUseReference> </subject2> </causalityAssessment> </component> </adverseEventAssessment> </component> <!--C.1.6.1: Are Additional Documents Available? --> <component typeCode="COMP"> <observationEvent classCode="OBS" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="false" /> </observationEvent> </component> <!--C.1.7: Does This Case Fulfil the Local Criteria for an Expedited Report?--> <component typeCode="COMP"> <observationEvent classCode="OBS" moodCode="EVN"> <code code="23" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="2.0" /> <value xsi:type="BL" value="true" /> </observationEvent> </component> <!--C.1.8.2: First Sender of This Case --> <outboundRelationship typeCode="SPRT"> <relatedInvestigation classCode="INVSTG" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" codeSystemVersion="2.0" /> <subjectOf2 typeCode="SUBJ"> <controlActEvent classCode="CACT" moodCode="EVN"> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.3" codeSystemVersion="2.0" /> </assignedEntity> </author> </controlActEvent> </subjectOf2> </relatedInvestigation> </outboundRelationship> <!--C.2.r: Primary Source(s) of Information - (1)--> <outboundRelationship typeCode="SPRT"> <!--C.2.r.5: Primary Source for Regulatory Purposes--> <priorityNumber value="1" /> <relatedInvestigation classCode="INVSTG" moodCode="EVN"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" codeSystemVersion="2.0" /> <subjectOf2 typeCode="SUBJ"> <controlActEvent classCode="CACT" moodCode="EVN"> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <addr> <!--C.2.r.2.5: Reporter's State or Province--> <state nullFlavor="MSK" /> </addr> <assignedPerson classCode="PSN" determinerCode="INSTANCE"> <name> <!--C.2.r.1.2: Reporter's Given Name--> <given nullFlavor="MSK" /> <!--C.2.r.1.4: Reporter's Family Name--> <family nullFlavor="MSK" /> </name> <!--C.2.r.4: Qualification--> <asQualifiedEntity classCode="QUAL"> <code code="5" codeSystem="2.16.840.1.113883.3.989.2.1.1.6" codeSystemVersion="2.0" /> </asQualifiedEntity> <!--C.2.r.3: Reporter's Country Code--> <asLocatedEntity classCode="LOCE"> <location determinerCode="INSTANCE" classCode="COUNTRY"> <code code="KE" codeSystem="1.0.3166.1.2.2" /> </location> </asLocatedEntity> </assignedPerson> </assignedEntity> </author> </controlActEvent> </subjectOf2> </relatedInvestigation> </outboundRelationship> <!--C.3: Information on Sender of Case Safety Report--> <subjectOf1 typeCode="SUBJ"> <controlActEvent classCode="CACT" moodCode="EVN"> <author typeCode="AUT"> <assignedEntity classCode="ASSIGNED"> <!--C.3.1: Sender Type--> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.7" codeSystemVersion="2.0" /> <addr> <!--C.3.4.1: Sender's Street Address--> <streetAddressLine>GLOBAL PHARMACOVIGILANCE MUELLERSTRASSE 178</streetAddressLine> <!--C.3.4.2: Sender's City--> <city>Berlin</city> </addr> <assignedPerson classCode="PSN" determinerCode="INSTANCE"> <name /> <!--C.3.4.5: Sender's Country Code--> <asLocatedEntity classCode="LOCE"> <location classCode="COUNTRY" determinerCode="INSTANCE"> <code code="DE" codeSystem="1.0.3166.1.2.2" /> </location> </asLocatedEntity> </assignedPerson> <representedOrganization classCode="ORG" determinerCode="INSTANCE"> <!--C.3.3.1: Sender's Department--> <name>GLOBAL PHARMACOVIGILANCE</name> <assignedEntity classCode="ASSIGNED"> <representedOrganization classCode="ORG" determinerCode="INSTANCE"> <!--C.3.2: Sender's Organization --> <name>Bayer AG</name> </representedOrganization> </assignedEntity> </representedOrganization> </assignedEntity> </author> </controlActEvent> </subjectOf1> <!--C.1.3: Type of Report --> <subjectOf2 typeCode="SUBJ"> <investigationCharacteristic classCode="OBS" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" codeSystemVersion="1.0" /> <value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.2" codeSystemVersion="2.0" /> </investigationCharacteristic> </subjectOf2> <!--C.1.9.1: Other Case Identifiers in Previous Transmissions --> <subjectOf2 typeCode="SUBJ"> <investigationCharacteristic classCode="OBS" moodCode="EVN"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" codeSystemVersion="1.0" /> <value xsi:type="BL" nullFlavor="NI" /> </investigationCharacteristic> </subjectOf2> </investigationEvent> </subject> </controlActProcess> </PORR_IN049016UV> <!--N.1.4: Batch Receiver Identifier--> <receiver typeCode="RCV"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="MOHKE" root="2.16.840.1.113883.3.989.2.1.3.14" /> </device> </receiver> <!--N.1.3: Batch Sender Identifier--> <sender typeCode="SND"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="BAYER" root="2.16.840.1.113883.3.989.2.1.3.13" /> </device> </sender> </MCCI_IN200100UV01>
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      • created2024-06-11 04:05:15
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      • version_no1.0
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      • file_date11-06-2024
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      • version_no1.0
      • created2024-06-11 04:41:17
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      • file_date11-06-2024
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      • version_no1.0
      • created2024-06-11 04:41:36
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      • version_no1.0
      • created2024-06-11 04:42:22
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      • version_no1.0
      • created2024-06-11 04:43:17
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      • version_no1.0
      • created2024-06-11 04:43:52
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      • file_date11-06-2024
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      • version_no1.0
      • created2024-06-11 04:45:35
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      • created2024-06-11 04:46:12
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      • alternative(null)
      • groupapplicant_indemnity_pi
      • descriptionIndemnity cover for PI, investigators and study Pharmacist. *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_indemnity_pi
      • version_no1.0
      • created2024-06-11 04:47:10
      • modified2024-06-11 09:01:24
      • pathdoc/1717570819_ppb_3.pdf
    • 19(array)
      • id693
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718026794_ppb_4.pdf
      • foreign_key86
      • dirnamedoc
      • basename1718026794_ppb_4.pdf
      • checksum92949893b8521659174674b8bf2361f8
      • alternative(null)
      • groupapplicant_indemnity_cover
      • descriptionClinical Trials Insurance cover for study participants *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_indemnity_cover
      • version_no1.3
      • created2024-06-11 04:47:30
      • modified2024-06-11 09:01:24
      • pathdoc/1718026794_ppb_4.pdf
    • 20(array)
      • id694
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1717987549_ppb_4.pdf
      • foreign_key86
      • dirnamedoc
      • basename1717987549_ppb_4.pdf
      • checksumf462776ce209dd588e0d5a537c6ef4bd
      • alternative(null)
      • groupapplicant_opinion_letter
      • descriptionCopy of favorable opinion letter from the local Ethics Review Committee (ERC). *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_opinion_letter
      • version_no1.0
      • created2024-06-11 04:47:54
      • modified2024-06-11 09:01:24
      • pathdoc/1717987549_ppb_4.pdf
    • 21(array)
      • id695
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1717987549_ppb_5.pdf
      • foreign_key86
      • dirnamedoc
      • basename1717987549_ppb_5.pdf
      • checksumf462776ce209dd588e0d5a537c6ef4bd
      • alternative(null)
      • groupapplicant_practice_license
      • descriptionCopy of current Practice Licenses for the Investigators and study Pharmacist *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_practice_license
      • version_no1.0
      • created2024-06-11 04:48:11
      • modified2024-06-11 09:01:24
      • pathdoc/1717987549_ppb_5.pdf
    • 22(array)
      • id696
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1718026800_ppb_7.pdf
      • foreign_key86
      • dirnamedoc
      • basename1718026800_ppb_7.pdf
      • checksum9bac759a37f0b8d2d1c8269f7373779f
      • alternative(null)
      • groupapplicant_approval_letter
      • descriptionCopy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_approval_letter
      • version_no1.0
      • created2024-06-11 04:48:27
      • modified2024-06-11 09:01:24
      • pathdoc/1718026800_ppb_7.pdf
    • 23(array)
      • id697
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1717987549_ppb_6.pdf
      • foreign_key86
      • dirnamedoc
      • basename1717987549_ppb_6.pdf
      • checksumf462776ce209dd588e0d5a537c6ef4bd
      • alternative(null)
      • groupapplicant_addendum
      • descriptionFor multicentre/multi-site studies, a site specific addendum for each of the proposed sites including among other things the sites’ capacity to carry out the study i.e personnel, equipment, laboratory etc
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_addendum
      • version_no1,0
      • created2024-06-11 04:48:44
      • modified2024-06-11 09:01:24
      • pathdoc/1717987549_ppb_6.pdf
    • 24(array)
      • id698
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/1717987549_ppb_7.pdf
      • foreign_key86
      • dirnamedoc
      • basename1717987549_ppb_7.pdf
      • checksumf462776ce209dd588e0d5a537c6ef4bd
      • alternative(null)
      • groupapplicant_statement
      • descriptionA signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading. *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_statement
      • version_no1.0
      • created2024-06-11 04:49:09
      • modified2024-06-11 09:01:24
      • pathdoc/1717987549_ppb_7.pdf
    • 25(array)
      • id699
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/psur_22.pdf
      • foreign_key86
      • dirnamedoc
      • basenamepsur_22.pdf
      • checksum7f9fcd7b3395094822f219c170e1848d
      • alternative(null)
      • groupapplicant_fees
      • descriptionPayment of fees *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_fees
      • version_no1.0
      • created2024-06-11 04:49:38
      • modified2024-06-11 09:01:24
      • pathdoc/psur_22.pdf
    • 26(array)
      • id700
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/psur_22_2.pdf
      • foreign_key86
      • dirnamedoc
      • basenamepsur_22_2.pdf
      • checksum7f9fcd7b3395094822f219c170e1848d
      • alternative(null)
      • groupstatistical_analysis_plan
      • descriptionStatistical Analysis Plan *
      • year(null)
      • file_date11-06-2024
      • pocket_namestatistical_analysis_plan
      • version_no1
      • created2024-06-11 04:49:55
      • modified2024-06-11 09:01:24
      • pathdoc/psur_22_2.pdf
    • 27(array)
      • id701
      • modelChecklist
      • file/var/www/ctr/app/webroot/media/transfer/doc/receipt_2.pdf
      • foreign_key86
      • dirnamedoc
      • basenamereceipt_2.pdf
      • checksumec7dd06888682d19e6fe1652f5536a94
      • alternative(null)
      • groupapplicant_signed_checklist
      • descriptionSigned Checklist *
      • year(null)
      • file_date11-06-2024
      • pocket_nameapplicant_signed_checklist
      • version_no1
      • created2024-06-11 04:50:29
      • modified2024-06-11 09:01:24
      • pathdoc/receipt_2.pdf
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(empty)
• redir
• $request->data(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • Review(empty)
  • ActiveInspector(empty)
  • ManagerReview(empty)
  • Acceptance(empty)
  • Amendment(empty)
  • InvestigatorContact(empty)
  • ApplicationStage(empty)
  • Pharmacist(empty)
  • EthicalCommittee(empty)
  • AnnualLetter(empty)
  • AmendmentLetter(empty)
  • AmendmentApproval(empty)
  • AmendmentApprovalSummary(empty)
  • Organization(empty)
  • SiteDetail(empty)
  • Placebo(empty)
  • Sponsor(empty)
  • SiteInspection(empty)
  • Sae(empty)
  • Ciom(empty)
  • StudyRoute(empty)
  • Manufacturer(empty)
  • Reassignment(empty)
  • Attachment(empty)
  • AnnualApproval(empty)
  • AmendmentChecklist(empty)
  • Reminder(empty)
  • ParticipantFlow(empty)
  • Budget(empty)
  • Deviation(empty)
  • Document(empty)
  • CoverLetter(empty)
  • Protocol(empty)
  • PatientLeaflet(empty)
  • Brochure(empty)
  • GmpCertificate(empty)
  • Cv(empty)
  • Finance(empty)
  • Declaration(empty)
  • IndemnityCover(empty)
  • OpinionLetter(empty)
  • ApprovalLetter(empty)
  • Statement(empty)
  • ParticipatingStudy(empty)
  • Addendum(empty)
  • Registration(empty)
  • Fee(empty)
  • Checklist(empty)
  • StudyMonitor(empty)
  • ProtocolOutsource(empty)
  • Outsource(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6DebugTimer
  • 7Toolbar
  • 8HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/ctr/lib
• 3/usr/share/php
• 4-> /var/www/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
    • 1APP/Model/Behavior/TimestampBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/Review.php
    • 5APP/Model/ActiveInspector.php
    • 6APP/Model/Amendment.php
    • 7APP/Model/InvestigatorContact.php
    • 8APP/Model/ApplicationStage.php
    • 9APP/Model/Pharmacist.php
    • 10APP/Model/EthicalCommittee.php
    • 11APP/Model/AnnualLetter.php
    • 12APP/Model/AmendmentLetter.php
    • 13APP/Model/AmendmentApproval.php
    • 14APP/Model/Organization.php
    • 15APP/Model/SiteDetail.php
    • 16APP/Model/Placebo.php
    • 17APP/Model/Sponsor.php
    • 18APP/Model/SiteInspection.php
    • 19APP/Model/Sae.php
    • 20APP/Model/Ciom.php
    • 21APP/Model/StudyRoute.php
    • 22APP/Model/Manufacturer.php
    • 23APP/Model/Reassignment.php
    • 24APP/Model/Attachment.php
    • 25APP/Model/Reminder.php
    • 26APP/Model/ParticipantFlow.php
    • 27APP/Model/Budget.php
    • 28APP/Model/Deviation.php
    • 29APP/Model/StudyMonitor.php
    • 30APP/Model/ProtocolOutsource.php
    • 31APP/Model/Outsource.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
    • Behavior(array)
      • 0Media/Model/Behavior/TransferBehavior.php
      • 1Media/Model/Behavior/CouplerBehavior.php
      • 2Media/Model/Behavior/MetaBehavior.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php