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• applications/index/status:suspended

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1787004538
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionview
• named(empty)
• pass(array)
  • 07
• isAjax(false)

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Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• application(array)
  • Application(array)
    • id7
    • user_id29
    • application_id(null)
    • is_child0
    • trial_status_id4
    • total_sites(null)
    • abstract_of_study<p> kjahkjhjkhjk</p>
    • study_title<p> gjhsghjGHJGHJ</p>
    • laymans_summary<p> jhjkhkjhkjhkjk</p>
    • short_titlesample short title come here
    • protocol_noECCT/24/02/03
    • reference_no(null)
    • version_nov4
    • date_of_protocol22-02-2024
    • study_drugsss
    • disease_conditiondddd
    • product_type_biologicals1
    • product_type_proteins0
    • product_type_immunologicals1
    • product_type_vaccines0
    • product_type_hormones0
    • product_type_toxoid0
    • product_type_chemical0
    • product_type_medical_device0
    • product_type_chemical_name
    • product_type_medical_device_name
    • comparatorYes
    • comparator_namessss
    • comparator_registered2
    • comparator_countries22222
    • ecct_not_applicable0
    • ecct_ref_number
    • email_addressjkiprotich@intellisoftkenya.com
    • applicant_covering_letter1
    • applicant_protocol1
    • applicant_patient_information1
    • applicant_investigators_brochure1
    • applicant_investigators_cv1
    • applicant_signed_declaration1
    • applicant_financial_declaration1
    • applicant_gmp_certificate1
    • applicant_indemnity_cover1
    • applicant_opinion_letter1
    • applicant_approval_letter1
    • applicant_statement1
    • applicant_participating_countries(null)
    • applicant_addendum1
    • applicant_fees1
    • applicant_complete_form(null)
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    • applicant_prev_data1
    • applicant_stability_data1
    • applicant_analysis_cert1
    • applicant_pictorial_sample1
    • applicant_gcp_training1
    • applicant_dsmb_charter1
    • applicant_detailed_budget1
    • applicant_indemnity_pi1
    • applicant_practice_license1
    • applicant_registration_ctr(null)
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    • applicant_hard_copies(null)
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    • statistical_analysis_plan1
    • applicant_contractual_agreement1
    • declaration_applicantffff
    • declaration_date122-02-2024
    • declaration_principal_investigatorsssss
    • declaration_date215-02-2024
    • protocol_not_ai_generated0
    • placebo_presentNo
    • study_objectives<p> HGDHGDH</p>
    • principal_inclusion_criteria<p> saFAGFGY</p>
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    • primary_end_points<p> ahHDKHKJ</p>
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    • trial_administration_humans0
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    • other_details_regulatory_approved<p> ddddd</p>
    • other_details_regulatory_rejected<p> ddddddd</p>
    • other_details_regulatory_halted<p> ddddddd</p>
    • estimated_durationdddd
    • design_controlled_randomised
    • design_controlled_open
    • design_controlled_single_blind
    • design_controlled_double_blind
    • design_controlled_parallel_group
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    • design_controlled_other_medicinal
    • design_controlled_placebo
    • design_controlled_medicinal_other
    • design_controlled_medicinal_specify
    • single_site_member_stateYes
    • location_of_areasome
    • single_site_physical_addresssome
    • single_site_contact_personsome
    • single_site_telephone0700432321
    • multiple_sites_member_stateNo
    • multiple_countriesNo
    • multiple_member_states
    • number_of_sites
    • multi_country_list
    • data_monitoring_committeeNo
    • total_enrolment_per_siteKJHJH
    • total_participants_worldwideSSSS
    • population_less_than_18_yearsYes
    • population_uteroYes
    • population_preterm_newbornYes
    • population_newbornNo
    • population_infant_and_toddlerYes
    • population_childrenYes
    • population_adolescentNo
    • population_above_18Yes
    • population_adultNo
    • population_elderlyYes
    • gender_female1
    • gender_male1
    • subjects_healthyNo
    • subjects_patientsNo
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    • subjects_women_child_bearingNo
    • subjects_women_using_contraceptionNo
    • subjects_pregnant_womenNo
    • subjects_nursing_womenNo
    • subjects_emergency_situationNo
    • subjects_incapable_consentNo
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    • subjects_othersNo
    • subjects_others_specify
    • investigator1_given_namewwewe
    • investigator1_middle_name
    • investigator1_family_nameeeeee
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    • investigator1_professional_addresseeeeee
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    • investigator1_emailsample@gmail.com
    • organisations_transferred_Yes
    • number_participantsdhkjhkjfhK
    • notification<p> dddddada</p>
    • approval_date28-02-2024
    • submitted1
    • deleted0
    • deleted_date(null)
    • deactivated0
    • date_submitted22-02-2024
    • unsubmitted1
    • initial_date_submitted01-02-2024
    • admin_stopped1
    • admin_stopped_reasonhey
    • approved0
    • approved_reasonApproved
    • approved_date(null)
    • final_report(null)
    • implication_results(null)
    • quantity_imported(null)
    • quantity_dispensed(null)
    • quantity_destroyed(null)
    • quantity_exported(null)
    • balance_site(null)
    • final_date(null)
    • ecitizen_invoice303020
    • modified2024-06-01 11:05:05
    • created2024-01-17 13:27:23
    • ai_content(null)
  • User(array)
    • id29
    • usernamejkiprotich
    • password547f0111bc877d5579f28409dcb3dafc5439c785
    • confirm_password547f0111bc877d5579f28409dcb3dafc5439c785
    • nameJapheth Kiprotich
    • emailjkiprotich@intellisoftkenya.com
    • national_id_number32645167
    • sponsor(null)
    • sponsor_emailjkiprotich@intellisoftkenya.com
    • qualificationDentist
    • phone_no254724743788
    • name_of_institution
    • institution_physical
    • institution_address
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    • country_id115
    • group_id5
    • activation_key
    • forgot_password0
    • is_active1
    • deactivated0
    • created2024-01-19 06:00:03
    • modified2024-10-16 14:11:49
  • TrialStatus(array)
    • id4
    • valueStopped
    • nameStopped
    • created2012-10-19 16:08:51
    • modified2020-04-16 10:04:18
  • Review(empty)
  • InternalReview(empty)
  • ActiveInspector(array)
    • 0(array)
      • id9
      • user_id33
      • application_id7
      • typerequest
      • assessment_type(null)
      • titlePPB request
      • text
      • summary(null)
      • recommendation(null)
      • notified0
      • accepted(null)
      • conflict(null)
      • statusUnsubmitted
      • created2024-03-12 06:47:32
      • modified2024-03-12 06:47:32
  • ManagerReview(empty)
  • Acceptance(empty)
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      • laymans_summary
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      • disease_condition
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      • product_type_proteins(null)
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      • types_and_phases
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      • email_address(null)
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      • placebo_present
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      • design_controlled_placebo
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      • submitted1
      • date_submitted2025-02-12 13:05:45
      • modified2025-02-12 13:05:45
      • created2024-05-23 16:27:58
    • 1(array)
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      • submitted1
      • date_submitted2025-02-12 14:21:08
      • modified2025-02-12 14:21:08
      • created2025-02-12 14:20:58
    • 2(array)
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  • AnnualLetter(array)
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      • content<h3 style="text-align: center;"> <span style="font-size: 12px;"><span style="font-family: "bookman old style", serif;"><img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></span></span></h3> <p style="text-align: center;"> <span style="font-family: "bookman old style", serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></p> <p style="text-align: center;"> <span style="font-family: "bookman old style", serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></p> <table style="border-width: 0px; border-style: initial; border-color: initial; width: 899px;"> <tbody> <tr> <td style="border-width: 0px; border-style: initial; border-color: initial; width: 295px;"> <div id="left-editor"> <p> <span style="font-family: "bookman old style", serif;">Telegram: "MINHEALTH", Nairobi</span></p> <p> <span style="font-family: "bookman old style", serif;">Cell phone: 0709 770 100</span></p> <p> <span style="font-family: "bookman old style", serif;">Email: info@pharmacyboardkenya.org</span></p> <p> <span style="font-family: "bookman old style", serif;">Website: web.pharmacyboardkenya.org</span></p> </div> </td> <td style="border-width: 0px; border-style: initial; border-color: initial; width: 295px;">  </td> <td style="border-width: 0px; border-style: initial; border-color: initial; width: 295px;"> <div id="right-editor"> <p> <span style="font-family: "bookman old style", serif;">Pharmacy and Poisons Board House</span></p> <p> <span style="font-family: "bookman old style", serif;">Along Lenana Road</span></p> <p> <span style="font-family: "bookman old style", serif;">P.O. Box 27663-00506</span></p> <p> <span style="font-family: "bookman old style", serif;">NAIROBI</span></p> </div> </td> </tr> </tbody> </table> <address> <span style="font-family: "bookman old style", serif;"> </span></address> <address> <span style="font-family: "bookman old style", serif;">When replying please quote</span></address> <p> <span style="font-family: "bookman old style", serif;"><strong>Ref.</strong> <strong>No.</strong> <strong>ECCT/1/2024-ECCT/24/06/03                                                                                                                                                                             3 Jan 2025</strong></span></p> <p> <span style="font-family: "bookman old style", serif;"><strong>Javan Ayoma,</strong></span></p> <p> <span style="font-family: "bookman old style", serif;"><strong>Principal</strong> <strong>Investigator</strong> <strong>ECCT/24/06/03,</strong></span></p> <p> <span style="font-family: "bookman old style", serif;"><strong>BTC Drive,</strong></span></p> <p> <span style="font-family: "bookman old style", serif;">Dear Sir/Madam,</span></p> <p> <span style="font-family: "bookman old style", serif;"><strong><u>Re: ECCT/24/06/03 : Initial Approval;</u></strong></span></p> <p> <strong><u>Comprehensive Analysis of Genetic Markers to Predict Efficacy and Personalize Treatment Strategies in Cancer Patients: A Multi-Center Prospective Cohort Study</u></strong></p> <p> <strong><u>  Genomic Markers for Predicting</u></strong><strong style="font-family: "bookman old style", serif;"><u>.</u></strong></p> <p>  </p> <p> <span style="font-family: "bookman old style", serif;">Reference is made to the above study.</span></p> <p> <span style="font-family: "bookman old style", serif;">We acknowledge receipt of the following documents;</span></p> <div style="margin-left: 15px;"> <span style="font-family: "bookman old style", serif;">1. Cover Letter (Should list all the submitted documents, their version numbers and dates)<br /> <a href="/attachments/download/750">men_s_mental_health_awareness_6.pdf</a> dated 18th June 2024 Version 1.0<br /> 2. The Study Protocol<br /> <a href="/attachments/download/751">men_s_mental_health_awareness_7.pdf</a> dated 18th June 2024 Version 1.0<br /> 3. Registration of the study at Pan African Clinical Trials Registry https://pactr.samrc.ac.za<br /> <a href="/attachments/download/752">men_s_mental_health_awareness_8.pdf</a> dated 18th June 2024 Version 1.0<br /> 4. Patient Information leaflet and Informed consent form<br /> <a href="/attachments/download/753">men_s_mental_health_awareness_9.pdf</a> dated 18th June 2024 Version 2.1<br /> 5. Investigators Brochure/Package inserts<br /> <a href="/attachments/download/754">1718068595_ppb.pdf</a> dated 18th June 2024 Version 1.5<br /> 6. Investigational Medicinal Product Dossier (IMPD)<br /> <a href="/attachments/download/755">1718068595_ppb_2.pdf</a> dated 18th June 2024 Version 2.0<br /> 7. Adequate data and information from previous studies and Phases to support carrying out of the current study<br /> <a href="/attachments/download/756">1718068595_ppb_3.pdf</a> dated 18th June 2024 Version 1.0<br /> 8. Stability data of the investigational product<br /> <a href="/attachments/download/757">1718068595_ppb_4.pdf</a> dated 18th June 2024 Version 2.1<br /> 9. GMP certificate of the investigational product from the site of manufacture<br /> <a href="/attachments/download/758">1718068595_ppb_5.pdf</a> dated 18th June 2024 Version 2.5<br /> 10. Certificate of Analysis of the investigational product<br /> <a href="/attachments/download/759">1718068595_ppb_6.pdf</a> dated 18th June 2024 Version 3.4<br /> 11. Pictorial Sample of the investigational products. This sample should include the text of the labeling to be used<br /> <a href="/attachments/download/760">1718068595_ppb_7.pdf</a> dated 18th June 2024 Version 2.7<br /> 12. Signed investigator(s) CV(s) including that of study Pharmacist (NB: The CV should include the current workload of the Principal Investigator )<br /> <a href="/attachments/download/761">1718068595_ppb_8.pdf</a> dated 18th June 2024 Version 5.0<br /> 13. Evidence of contractual agreement between sponsor and Principal Investigator.<br /> <a href="/attachments/download/762">1718068595_ppb_9.pdf</a> dated 18th June 2024 Version 4.0<br /> 14. Evidence of recent GCP training of the core study staff<br /> <a href="/attachments/download/763">1718026860_ppb_4.pdf</a> dated 18th June 2024 Version 3.4<br /> 15. DSMB Charter including the composition and meeting schedule<br /> <a href="/attachments/download/764">1718026800_ppb_8.pdf</a> dated 18th June 2024 Version 5.6<br /> 16. Detailed budget of the study<br /> <a href="/attachments/download/765">1718026794_ppb_5.pdf</a> dated 18th June 2024 Version 1.5<br /> 17. Financial declaration by Sponsor and/or PI<br /> <a href="/attachments/download/766">1717987549_ppb_8.pdf</a> dated 18th June 2024 Version 3.4<br /> 18. Signed Declaration by Sponsor or Principal investigator that the study will be carried out according to the protocol and applicable laws, regulations and GCP requirements.<br /> <a href="/attachments/download/767">psur_22_3.pdf</a> dated 18th June 2024 Version 6.8<br /> 19. Indemnity cover for PI, investigators and study Pharmacist.<br /> <a href="/attachments/download/768">psur_22_4.pdf</a> dated 18th June 2024 Version 4.4<br /> 20. Clinical Trials Insurance cover for study participants<br /> <a href="/attachments/download/769">1717987549_ppb_9.pdf</a> dated 18th June 2024 Version 6.2<br /> 21. Copy of favorable opinion letter from the local Ethics Review Committee (ERC).<br /> <a href="/attachments/download/770">psur_22_5.pdf</a> dated 18th June 2024 Version 3.3<br /> 22. Copy of current Practice Licenses for the Investigators and study Pharmacist<br /> <a href="/attachments/download/771">1718068595_ppb_10.pdf</a> dated 18th June 2024 Version 3.4<br /> 23. Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable<br /> <a href="/attachments/download/772">1718068595_ppb_11.pdf</a> dated 18th June 2024 Version 6<br /> 24. For 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<br /> <a href="/attachments/download/773">men_s_mental_health_awareness_10.pdf</a> dated 18th June 2024 Version 5<br /> 25. A 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.<br /> <a href="/attachments/download/774">receipt_2_2.pdf</a> dated 18th June 2024 Version 6<br /> 26. Payment of fees<br /> <a href="/attachments/download/775">receipt_2_3.pdf</a> dated 18th June 2024 Version 7<br /> 27. Statistical Analysis Plan<br /> <a href="/attachments/download/776">receipt_2_4.pdf</a> dated 18th June 2024 Version 2<br /> 28. Signed Checklist<br /> <a href="/attachments/download/777">receipt_2_5.pdf</a> dated 18th June 2024 Version 2</span></div> <p> After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials notes the following:</p> <p> <strong>     </strong></p> <p> The Pharmacy and Poisons Board Expert Committee on Clinical Trials grants approval to the study:</p> <p> Comprehensive Analysis of Genetic Markers to Predict Efficacy and Personalize Treatment Strategies in Cancer Patients: A Multi-Center Prospective Cohort Study</p> <p> ECCT/24/06/03<strong>.</strong></p> <p>  </p> <p> This approval is <strong>valid</strong> <strong>for</strong> <strong>one</strong> <strong>year</strong> and in case the study extends beyond one year from the date of this letter, you are required to seek approval before proceeding with the study. The expiry date is <b>19th June 2025</b></p> <ol> <li> You should ensure compliance with Kenya Legal, regulatory and GCP requirements</li> <li> All safety reports should be submitted to ECCT as per the current PPB clinical trials guidelines</li> <li> It is your responsibility to inform the PPB of any changes to the protocol, research design and procedures that could introduce new or more than minimum risk to human subjects</li> <li> You are also reminded that upon conclusion of the study, you shall be required to submit the executive summary report of the study within 30 days while a copy of the clinical study report in ICH E3 format should be submitted to us within 180 days of the study closure</li> </ol> <div> <p> Yours Sincerely,</p> </div> <p> <span style="font-family: "bookman old style", serif;">:signature</span></p> <p> <span style="font-family: "bookman old style", serif;">:approver</span></p> <p> <span style="font-family: "bookman old style", serif;"><strong><u>For Chief Executive Officer</u></strong></span></p> <p>  </p>
      • qrcode(null)
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      • created2025-01-06 10:46:03
      • modified2025-01-06 10:57:33
  • AmendmentLetter(array)
    • 0(array)
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      • approval_noPPB/ECCT/24/02/03/2024(4)
      • content<h3 style="text-align: center;"> <span style="font-family:bookman old style,serif;"><img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></span></h3> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></p> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></p> <p> <span style="font-family:bookman old style,serif;">Along Lenana Road </span></p> <p> <span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></p> <p> <span style="font-family:bookman old style,serif;">NAIROBI </span></p> </div> </td> </tr> </tbody> </table> <p> <span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/02/03 : Amendment Approval; <p> gjhsghjGHJGHJ</p> .</u></strong></span></p> <p> <span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></p> <p> <span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></p> <div style="margin-left: 15px;"> <span style="font-family:bookman old style,serif;">1. test 15th files<br><a href="http://45.79.161.190:8080/attachments/download/450">arms_7.png</a> dated 7th March 2024 Version 2<br>2. sample description <br><a href="http://45.79.161.190:8080/attachments/download/451">arms_8.png</a> dated 7th March 2024 Version 3<br>3. Some First Amendment File<br><a href="http://45.79.161.190:8080/attachments/download/452">arms_10.png</a> dated 7th March 2024 Version 2<br>4. second<br><a href="http://45.79.161.190:8080/attachments/download/453">arms_11.png</a> dated 7th March 2024 Version 4<br>5. Second File<br><a href="http://45.79.161.190:8080/attachments/download/454">arms_12.png</a> dated 8th March 2024 Version 3<br>6. Third file<br><a href="http://45.79.161.190:8080/attachments/download/455">arms_13.png</a> dated 7th March 2024 Version 7<br>7. hey hey hye <br><a href="http://45.79.161.190:8080/attachments/download/456">arms_14.png</a> dated 8th March 2024 Version 54<br>8. w<br><a href="http://45.79.161.190:8080/attachments/download/457">arms_15.png</a> dated 8th March 2024 Version 65<br></span></div> <p> <span style="font-family:bookman old style,serif;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study <strong><p> gjhsghjGHJGHJ</p> </strong><strong>.</strong> <strong>(ECCT/24/02/03).</strong></span></p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Yours Sincerely,</span></p> <p> <span style="font-family:bookman old style,serif;">:signature</span></p> <p> <span style="font-family:bookman old style,serif;">:approver</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></p> <p>  </p>
      • 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
      • approvermanager
      • approval_date2024-03-12
      • expiry_date2025-02-28
      • statusamd-1
      • submitted0
      • deleted0
      • deleted_date(null)
      • created2024-03-12 06:54:56
      • modified2024-03-12 06:54:56
    • 1(array)
      • id5
      • application_id7
      • approval_noPPB/ECCT/24/02/03/2024(5)
      • content<h3 style="text-align: center;"> <span style="font-family:bookman old style,serif;"><img height="86" src="https://lh7-us.googleusercontent.com/eOWVvo3AHW74GguHveDaqdgy3YwNZqOqOO0QtscRoV4hJfcvt8Q6v4oLN3beVNvClvoD1ncu1RhB5D4iuAY-5R9h1aD2lEGqUorBVcQ0azfxsdvIz-WhbF3rA9-VQomtusnP2bNZTuYLFTC6vQ46nQ" style="background-color: transparent; color: rgb(0, 0, 0); font-family: "Bookman Old Style", serif; font-size: 11pt; white-space-collapse: preserve; margin-left: 0px; margin-top: 0px;" width="116" /></span></h3> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>MINISTRY</strong> <strong>OF</strong> <strong>HEALTH</strong></span></p> <p style="text-align: center;"> <span style="font-family:bookman old style,serif;"><strong>PHARMACY</strong> <strong>AND</strong> <strong>POISONS</strong> <strong>BOARD</strong></span></p> <table style="width: 100%; border:0px"> <tbody> <tr> <td style="width: 33.33%; border:0px"> <div id="left-editor"> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Telegram: "MINHEALTH", Nairobi</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Cell phone: 0709 770 100</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Email: info@pharmacyboardkenya.org</span></span></p> <p> <span style="font-family:bookman old style,serif;"><span style="font-size:12px;">Website: web.pharmacyboardkenya.org</span></span></p> </div> </td> <td style="width: 33.33%;border:0px">  </td> <td style="width: 33.33%;border:0px"> <div id="right-editor"> <p> <span style="font-family:bookman old style,serif;">Pharmacy and Poisons Board House</span></p> <p> <span style="font-family:bookman old style,serif;">Along Lenana Road </span></p> <p> <span style="font-family:bookman old style,serif;">P.O. Box 27663-00506 </span></p> <p> <span style="font-family:bookman old style,serif;">NAIROBI </span></p> </div> </td> </tr> </tbody> </table> <p> <span style="font-family:bookman old style,serif;">Dear Sir/Madam,</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>Re: ECCT/24/02/03 : Amendment Approval; <p> gjhsghjGHJGHJ</p> .</u></strong></span></p> <p> <span style="font-family:bookman old style,serif;">Reference is made to the above study.</span></p> <p> <span style="font-family:bookman old style,serif;">We acknowledge receipt of the following documents;</span></p> <div style="margin-left: 15px;"> <span style="font-family:bookman old style,serif;">1. test 15th files<br><a href="http://45.79.161.190:8080/attachments/download/450">arms_7.png</a> dated 7th March 2024 Version 2<br>2. sample description <br><a href="http://45.79.161.190:8080/attachments/download/451">arms_8.png</a> dated 7th March 2024 Version 3<br>3. Some First Amendment File<br><a href="http://45.79.161.190:8080/attachments/download/452">arms_10.png</a> dated 7th March 2024 Version 2<br>4. second<br><a href="http://45.79.161.190:8080/attachments/download/453">arms_11.png</a> dated 7th March 2024 Version 4<br>5. Second File<br><a href="http://45.79.161.190:8080/attachments/download/454">arms_12.png</a> dated 8th March 2024 Version 3<br>6. Third file<br><a href="http://45.79.161.190:8080/attachments/download/455">arms_13.png</a> dated 7th March 2024 Version 7<br>7. hey hey hye <br><a href="http://45.79.161.190:8080/attachments/download/456">arms_14.png</a> dated 8th March 2024 Version 54<br>8. w<br><a href="http://45.79.161.190:8080/attachments/download/457">arms_15.png</a> dated 8th March 2024 Version 65<br></span></div> <p> <span style="font-family:bookman old style,serif;">After review of the documents, the Pharmacy and Poisons Board Expert Committee on Clinical Trials grants amendment approval to the study <strong><p> gjhsghjGHJGHJ</p> </strong><strong>.</strong> <strong>(ECCT/24/02/03).</strong></span></p> <p>  </p> <p> <span style="font-family:bookman old style,serif;">Yours Sincerely,</span></p> <p> <span style="font-family:bookman old style,serif;">:signature</span></p> <p> <span style="font-family:bookman old style,serif;">:approver</span></p> <p> <span style="font-family:bookman old style,serif;"><strong><u>For Chief Executive Officer</u></strong></span></p> <p>  </p>
      • 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      • approval_date2024-03-14
      • expiry_date2025-02-28
      • statusamd-1
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      • deleted0
      • deleted_date(null)
      • created2024-03-14 06:40:14
      • modified2024-03-14 06:40:14
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      • statusapproved
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      • deleted_date(null)
      • created2024-03-12 06:54:55
      • modified2024-03-12 06:54:55
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      • statusapproved
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      • deleted_date(null)
      • created2024-03-14 06:40:14
      • modified2024-03-14 06:40:14
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      • medical_writingNo
      • other_dutiesYes
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      • created2024-02-22 01:39:23
      • modified2024-02-22 02:11:48
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      • created2024-02-22 01:39:23
      • modified2024-02-22 02:11:48
  • Placebo(array)
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      • created2024-02-22 01:39:23
      • modified2024-02-22 02:11:48
  • Sponsor(array)
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      • email_addresssample@gmail.com
      • created2024-02-22 01:39:23
      • modified2024-02-22 02:11:48
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      • version_no(null)
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      • events_summary(null)
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      • approved0
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      • created2024-02-27 09:45:13
      • modified2024-03-04 09:20:52
  • Sae(empty)
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      • reference_no(null)
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      • reporter_emailjkiprotich@intellisoftkenya.com
      • 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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      • e2b_content<?xml version="1.0" encoding="ISO-8859-1"?> <!DOCTYPE ichicsr SYSTEM "http://eudravigilance.ema.europa.eu/dtd/icsr21xml.dtd"> <ichicsr lang="en"> <ichicsrmessageheader lang="en"> <messagetype>ichicsr</messagetype> <messageformatversion>2.1</messageformatversion> <messageformatrelease>2.0</messageformatrelease> <messagenumb>KE-PPB-2024-6335</messagenumb> <messagesenderidentifier>PPB</messagesenderidentifier> <messagereceiveridentifier>KE</messagereceiveridentifier> <messagedateformat>204</messagedateformat> <messagedate>20240523115150</messagedate> </ichicsrmessageheader> <safetyreport lang="en"> <safetyreportversion>1</safetyreportversion> <safetyreportid>KE-PPB-SADR/2024/18</safetyreportid> <primarysourcecountry>KE</primarysourcecountry> <occurcountry>KE</occurcountry> <transmissiondateformat/> <transmissiondate/> <reporttype>1</reporttype> <serious>2</serious> <seriousnessdeath>2</seriousnessdeath> <seriousnesslifethreatening>2</seriousnesslifethreatening> <seriousnesshospitalization>2</seriousnesshospitalization> <seriousnessdisabling>2</seriousnessdisabling> <seriousnesscongenitalanomali>2</seriousnesscongenitalanomali> <seriousnessother>2</seriousnessother> <receivedateformat>102</receivedateformat> <receivedate>20240506</receivedate> <receiptdateformat>102</receiptdateformat> <receiptdate>20240506</receiptdate> <additionaldocument>2</additionaldocument> <documentlist></documentlist> <fulfillexpeditecriteria>2</fulfillexpeditecriteria> <authoritynumb>KE-PPB-SADR/2024/18</authoritynumb> <companynumb/> <duplicate>0</duplicate> <casenullification>0</casenullification> <nullificationreason/> <medicallyconfirm>1</medicallyconfirm> <primarysource> <reportergivename>Lawrence</reportergivename> <reporterfamilyname>ojunga otieno</reporterfamilyname> <reporterorganization>St Camillus Mission Hospital</reporterorganization> <reporterdepartment/> <reporterstreet>0700212343</reporterstreet> <reportercity/> <reporterstate/> <reporterpostcode/> <reportercountry>KE</reportercountry> <qualification>3</qualification> <literaturereference/> <studyname/> <sponsorstudynumb/> <observestudytype/> </primarysource> <sender> <sendertype>3</sendertype> <senderorganization>Pharmacy and Poisons Board</senderorganization> <senderdepartment>Department of Pharmacovigilance</senderdepartment> <sendertitle>Dr.</sendertitle> <sendergivename>Christabel</sendergivename> <sendermiddlename>N.</sendermiddlename> <senderfamilyname>Khaemba</senderfamilyname> <senderstreetaddress>P.O. Box:27663-00506</senderstreetaddress> <sendercity>Nairobi</sendercity> <senderstate/> <senderpostcode>00506</senderpostcode> <sendercountrycode>KE</sendercountrycode> <sendertel>720608811</sendertel> <sendertelextension/> <sendertelcountrycode>254</sendertelcountrycode> <senderfax>2713409</senderfax> <senderfaxextension>20</senderfaxextension> <senderfaxcountrycode>254</senderfaxcountrycode> <senderemailaddress>pv@pharmacyboardkenya.org</senderemailaddress> </sender> <receiver> <receivertype/> <receiverorganization/> <receiverdepartment/> <receivertitle/> <receivergivename/> <receivermiddlename/> <receiverfamilyname/> <receiverstreetaddress/> <receivercity/> <receiverstate/> <receiverpostcode/> <receivercountrycode/> <receivertel/> <receivertelextension/> <receivertelcountrycode/> <receiverfax/> <receiverfaxextension/> <receiverfaxcountrycode/> <receiveremailaddress/> </receiver> <patient> <patientinitial>IBO</patientinitial> <patientgpmedicalrecordnumb>01</patientgpmedicalrecordnumb> <patientspecialistrecordnumb>01</patientspecialistrecordnumb> <patienthospitalrecordnumb>01</patienthospitalrecordnumb> <patientinvestigationnumb/> <patientbirthdateformat>102</patientbirthdateformat> <patientbirthdate>19940202</patientbirthdate> <patientonsetage/> <patientonsetageunit/> <gestationperiod/> <gestationperiodunit/> <patientagegroup>5</patientagegroup> <patientweight>70</patientweight> <patientheight>160</patientheight> <patientsex>1</patientsex> <lastmenstrualdateformat/> <patientlastmenstrualdate/> <patientmedicalhistorytext>paticipated in annual mass drug administration in the lasts 8 hours</patientmedicalhistorytext> <resultstestsprocedures>none</resultstestsprocedures> <patientdeath> <patientdeathdateformat/> <patientdeathdate/> <patientautopsyyesno/> </patientdeath> <reaction> <primarysourcereaction>Dizziness</primarysourcereaction> <reactionmeddraversionllt>23.0</reactionmeddraversionllt> <reactionmeddrallt>10013573</reactionmeddrallt> <reactionmeddraversionpt></reactionmeddraversionpt> <reactionmeddrapt></reactionmeddrapt> <termhighlighted/> <reactionstartdateformat> 102</reactionstartdateformat> <reactionstartdate>20240506</reactionstartdate> <reactionenddateformat/> <reactionenddate/> <reactionduration/> <reactiondurationunit/> <reactionfirsttime/> <reactionfirsttimeunit/> <reactionlasttime/> <reactionlasttimeunit/> <reactionoutcome>2</reactionoutcome> </reaction> <drug> <drugcharacterization>2</drugcharacterization> <medicinalproduct>ABZ Tablets</medicinalproduct> <obtaindrugcountry/> <drugbatchnumb/> <drugauthorizationnumb/> <drugauthorizationcountry/> <drugauthorizationholder/> <drugstructuredosagenumb>400</drugstructuredosagenumb> <drugstructuredosageunit>003</drugstructuredosageunit> <drugseparatedosagenumb/> <drugintervaldosageunitnumb/> <drugintervaldosagedefinition/> <drugcumulativedosagenumb/> <drugcumulativedosageunit/> <drugdosagetext/> <drugdosageform/> <drugadministrationroute>048</drugadministrationroute> <drugparadministration/> <reactiongestationperiod/> <reactiongestationperiodunit/> <drugindicationmeddraversion/> <drugindication>mass drug administration</drugindication> <drugstartdateformat>102</drugstartdateformat> <drugstartdate>20240506</drugstartdate> <drugstartperiod/> <drugstartperiodunit/> <druglastperiod/> <druglastperiodunit/> <drugenddateformat>102</drugenddateformat> <drugenddate>20240506</drugenddate> <drugtreatmentduration/> <drugtreatmentdurationunit/> <actiondrug></actiondrug> <drugrecurreadministration/> <drugadditional/> <activesubstance> <activesubstancename>ALBENDAZOLE</activesubstancename> </activesubstance> <drugreactionrelatedness> <drugreactionassesmeddraversion /> <drugreactionasses /> <drugassessmentsource/> <drugassessmentmethod /> <drugresult /> </drugreactionrelatedness> </drug> <drug> <drugcharacterization>1</drugcharacterization> <medicinalproduct>dec</medicinalproduct> <obtaindrugcountry/> <drugbatchnumb/> <drugauthorizationnumb/> <drugauthorizationcountry/> <drugauthorizationholder/> <drugstructuredosagenumb>400</drugstructuredosagenumb> <drugstructuredosageunit>003</drugstructuredosageunit> <drugseparatedosagenumb/> <drugintervaldosageunitnumb/> <drugintervaldosagedefinition/> <drugcumulativedosagenumb/> <drugcumulativedosageunit/> <drugdosagetext/> <drugdosageform/> <drugadministrationroute>048</drugadministrationroute> <drugparadministration/> <reactiongestationperiod/> <reactiongestationperiodunit/> <drugindicationmeddraversion/> <drugindication>mass drug adminisration</drugindication> <drugstartdateformat>102</drugstartdateformat> <drugstartdate>20240506</drugstartdate> <drugstartperiod/> <drugstartperiodunit/> <druglastperiod/> <druglastperiodunit/> <drugenddateformat>102</drugenddateformat> <drugenddate>20240506</drugenddate> <drugtreatmentduration/> <drugtreatmentdurationunit/> <actiondrug>6</actiondrug> <drugrecurreadministration/> <drugadditional/> <activesubstance> <activesubstancename>diethylcarbamazine</activesubstancename> </activesubstance> <drugreactionrelatedness> <drugreactionassesmeddraversion /> <drugreactionasses /> <drugassessmentsource/> <drugassessmentmethod /> <drugresult /> </drugreactionrelatedness> </drug> <summary> <narrativeincludeclinical>intense diziness,nausea and headache</narrativeincludeclinical> <reportercomment>managed with paracetamol 1g</reportercomment> <senderdiagnosismeddraversion /> <senderdiagnosis /> <sendercomment/> </summary> </patient> </safetyreport> </ichicsr>
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      • e2b_content<?xml version="1.0" encoding="UTF-8"?> <!DOCTYPE ichicsr SYSTEM "http://eudravigilance.ema.europa.eu/dtd/icsr21xml.dtd"> <ichicsr lang="en"> <ichicsrmessageheader lang="en"> <messagetype>ichicsr</messagetype> <messageformatversion>2.1</messageformatversion> <messageformatrelease>2.0</messageformatrelease> <messagenumb>KE-PPB-2024-14299</messagenumb> <messagesenderidentifier>PPB</messagesenderidentifier> <messagereceiveridentifier>KE</messagereceiveridentifier> <messagedateformat>204</messagedateformat> <messagedate>20240527105744</messagedate> </ichicsrmessageheader> <safetyreport lang="en"> <safetyreportversion>1</safetyreportversion> <safetyreportid>KE-PPB-AEFI/2023/6479</safetyreportid> <primarysourcecountry>KE</primarysourcecountry> <occurcountry>KE</occurcountry> <transmissiondateformat/> <transmissiondate/> <reporttype>1</reporttype> <serious>1</serious> <seriousnessdeath>2</seriousnessdeath> <seriousnesslifethreatening>2</seriousnesslifethreatening> <seriousnesshospitalization>2</seriousnesshospitalization> <seriousnessdisabling>2</seriousnessdisabling> <seriousnesscongenitalanomali>2</seriousnesscongenitalanomali> <seriousnessother>2</seriousnessother> <receivedateformat>102</receivedateformat> <receivedate>20231121</receivedate> <receiptdateformat>102</receiptdateformat> <receiptdate>20231121</receiptdate> <additionaldocument>2</additionaldocument> <documentlist></documentlist> <fulfillexpeditecriteria>2</fulfillexpeditecriteria> <authoritynumb>KE-PPB-AEFI/2023/6479</authoritynumb> <companynumb/> <duplicate/> <casenullification/> <nullificationreason/> <medicallyconfirm>1</medicallyconfirm> <primarysource> <reportergivename>Muthoni</reportergivename> <reporterfamilyname>Nyaga </reporterfamilyname> <reporterorganization>Kinoo Dispensary</reporterorganization> <reporterdepartment/> <reporterstreet/> <reportercity/> <reporterstate/> <reporterpostcode/> <reportercountry>KE</reportercountry> <qualification>2</qualification> <literaturereference/> <studyname/> <sponsorstudynumb/> <observestudytype/> </primarysource> <sender> <sendertype>3</sendertype> <senderorganization>Pharmacy and Poisons Board</senderorganization> <senderdepartment>Department of Pharmacovigilance</senderdepartment> <sendertitle>Dr.</sendertitle> <sendergivename>Christabel</sendergivename> <sendermiddlename>N.</sendermiddlename> <senderfamilyname>Khaemba</senderfamilyname> <senderstreetaddress>P.O. Box:27663-00506</senderstreetaddress> <sendercity>Nairobi</sendercity> <senderstate/> <senderpostcode>00506</senderpostcode> <sendercountrycode>KE</sendercountrycode> <sendertel>720608811</sendertel> <sendertelextension/> <sendertelcountrycode>254</sendertelcountrycode> <senderfax>2713409</senderfax> <senderfaxextension>20</senderfaxextension> <senderfaxcountrycode>254</senderfaxcountrycode> <senderemailaddress>pv@pharmacyboardkenya.org</senderemailaddress> </sender> <receiver> <receivertype/> <receiverorganization/> <receiverdepartment/> <receivertitle/> <receivergivename/> <receivermiddlename/> <receiverfamilyname/> <receiverstreetaddress/> <receivercity/> <receiverstate/> <receiverpostcode/> <receivercountrycode/> <receivertel/> <receivertelextension/> <receivertelcountrycode/> <receiverfax/> <receiverfaxextension/> <receiverfaxcountrycode/> <receiveremailaddress/> </receiver> <patient> <patientinitial>M A A</patientinitial> <patientgpmedicalrecordnumb></patientgpmedicalrecordnumb> <patientspecialistrecordnumb></patientspecialistrecordnumb> <patienthospitalrecordnumb></patienthospitalrecordnumb> <patientinvestigationnumb/> <patientbirthdateformat>602</patientbirthdateformat> <patientbirthdate></patientbirthdate> <patientonsetage>6</patientonsetage><patientonsetageunit>802</patientonsetageunit> <gestationperiod/> <gestationperiodunit/> <patientagegroup/> <patientweight/> <patientheight/> <patientsex>1</patientsex> <lastmenstrualdateformat/> <patientlastmenstrualdate/> <patientmedicalhistorytext></patientmedicalhistorytext> <resultstestsprocedures/> <patientdeath> <patientdeathdateformat/> <patientdeathdate/> <patientautopsyyesno/> </patientdeath> <reaction> <primarysourcereaction> Fever, </primarysourcereaction> <reactionmeddraversionllt>23.0</reactionmeddraversionllt> <reactionmeddrallt>Fontanelle bulging</reactionmeddrallt> <reactionmeddraversionpt/> <reactionmeddrapt/> <termhighlighted/> <reactionstartdateformat>102</reactionstartdateformat><reactionstartdate>20230901</reactionstartdate> <reactionenddateformat/> <reactionenddate/> <reactionduration/> <reactiondurationunit/> <reactionfirsttime/> <reactionfirsttimeunit/> <reactionlasttime/> <reactionlasttimeunit/> <reactionoutcome>1</reactionoutcome> </reaction> <drug> <drugcharacterization>1</drugcharacterization> <medicinalproduct>Novel oral polio vaccine type 2 (nOPV2)</medicinalproduct> <obtaindrugcountry/> <drugbatchnumb>22214222</drugbatchnumb> <drugauthorizationnumb/> <drugauthorizationcountry/> <drugauthorizationholder/> <drugstructuredosagenumb>1</drugstructuredosagenumb> <drugstructuredosageunit></drugstructuredosageunit> <drugseparatedosagenumb/> <drugintervaldosageunitnumb/> <drugintervaldosagedefinition/> <drugcumulativedosagenumb/> <drugcumulativedosageunit/> <drugdosagetext>1</drugdosagetext> <drugdosageform/> <drugadministrationroute/> <drugparadministration/> <reactiongestationperiod/> <reactiongestationperiodunit/> <drugindicationmeddraversion/> <drugindication/> <drugstartdateformat>102</drugstartdateformat> <drugstartdate>20230827</drugstartdate> <drugstartperiod/> <drugstartperiodunit/> <druglastperiod/> <druglastperiodunit/> <drugenddateformat/> <drugenddate/> <drugtreatmentduration/> <drugtreatmentdurationunit/> <actiondrug/> <drugrecurreadministration/> <drugadditional>10104723</drugadditional> <activesubstance> <activesubstancename></activesubstancename> </activesubstance> <drugreactionrelatedness> <drugreactionassesmeddraversion>23.0</drugreactionassesmeddraversion> <drugreactionasses>Fontanelle bulging</drugreactionasses> <drugassessmentsource/> <drugassessmentmethod/> <drugresult/> </drugreactionrelatedness> </drug> <summary> <narrativeincludeclinical>Infant was taken to Gertrude’s hospital after developing a bulging fontanelle for 6 days after oral polio vaccination. Parent noted the same bulging after vitamin A administration however resolved. </narrativeincludeclinical> <reportercomment/> <senderdiagnosismeddraversion>23.0</senderdiagnosismeddraversion> <senderdiagnosis></senderdiagnosis> <sendercomment/> </summary> </patient> </safetyreport> </ichicsr>
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      • reference_no(null)
      • user_id29
      • reporter_emailjkiprotich@intellisoftkenya.com
      • e2b_content<?xml version="1.0" encoding="UTF-8"?> <!DOCTYPE ichicsr SYSTEM "http://eudravigilance.ema.europa.eu/dtd/icsr21xml.dtd"> <ichicsr lang="en"> <ichicsrmessageheader lang="en"> <messagetype>ichicsr</messagetype> <messageformatversion>2.1</messageformatversion> <messageformatrelease>2.0</messageformatrelease> <messagenumb>KE-PPB-2024-1663</messagenumb> <messagesenderidentifier>PPB</messagesenderidentifier> <messagereceiveridentifier>KE</messagereceiveridentifier> <messagedateformat>204</messagedateformat> <messagedate>20240527125941</messagedate> </ichicsrmessageheader> <safetyreport lang="en"> <safetyreportversion>1</safetyreportversion> <safetyreportid>KE-PPB-AEFI/2024/22</safetyreportid> <primarysourcecountry>KE</primarysourcecountry> <occurcountry>KE</occurcountry> <transmissiondateformat/> <transmissiondate/> <reporttype>1</reporttype> <serious>2</serious> <seriousnessdeath>2</seriousnessdeath> <seriousnesslifethreatening>2</seriousnesslifethreatening> <seriousnesshospitalization>2</seriousnesshospitalization> <seriousnessdisabling>2</seriousnessdisabling> <seriousnesscongenitalanomali>2</seriousnesscongenitalanomali> <seriousnessother>2</seriousnessother> <receivedateformat>102</receivedateformat> <receivedate>20240527</receivedate> <receiptdateformat>102</receiptdateformat> <receiptdate>20240527</receiptdate> <additionaldocument>2</additionaldocument> <documentlist></documentlist> <fulfillexpeditecriteria>2</fulfillexpeditecriteria> <authoritynumb>KE-PPB-AEFI/2024/22</authoritynumb> <companynumb/> <duplicate/> <casenullification/> <nullificationreason/> <medicallyconfirm>1</medicallyconfirm> <primarysource> <reportergivename>Christine</reportergivename> <reporterfamilyname> </reporterfamilyname> <reporterorganization>Kasarani A 2</reporterorganization> <reporterdepartment/> <reporterstreet/> <reportercity/> <reporterstate/> <reporterpostcode/> <reportercountry>KE</reportercountry> <qualification>1</qualification> <literaturereference/> <studyname/> <sponsorstudynumb/> <observestudytype/> </primarysource> <sender> <sendertype>3</sendertype> <senderorganization>Pharmacy and Poisons Board</senderorganization> <senderdepartment>Department of Pharmacovigilance</senderdepartment> <sendertitle>Dr.</sendertitle> <sendergivename>Christabel</sendergivename> <sendermiddlename>N.</sendermiddlename> <senderfamilyname>Khaemba</senderfamilyname> <senderstreetaddress>P.O. Box:27663-00506</senderstreetaddress> <sendercity>Nairobi</sendercity> <senderstate/> <senderpostcode>00506</senderpostcode> <sendercountrycode>KE</sendercountrycode> <sendertel>720608811</sendertel> <sendertelextension/> <sendertelcountrycode>254</sendertelcountrycode> <senderfax>2713409</senderfax> <senderfaxextension>20</senderfaxextension> <senderfaxcountrycode>254</senderfaxcountrycode> <senderemailaddress>pv@pharmacyboardkenya.org</senderemailaddress> </sender> <receiver> <receivertype/> <receiverorganization/> <receiverdepartment/> <receivertitle/> <receivergivename/> <receivermiddlename/> <receiverfamilyname/> <receiverstreetaddress/> <receivercity/> <receiverstate/> <receiverpostcode/> <receivercountrycode/> <receivertel/> <receivertelextension/> <receivertelcountrycode/> <receiverfax/> <receiverfaxextension/> <receiverfaxcountrycode/> <receiveremailaddress/> </receiver> <patient> <patientinitial>L.M</patientinitial> <patientgpmedicalrecordnumb>22222</patientgpmedicalrecordnumb> <patientspecialistrecordnumb>22222</patientspecialistrecordnumb> <patienthospitalrecordnumb>22222</patienthospitalrecordnumb> <patientinvestigationnumb/> <patientbirthdateformat>102</patientbirthdateformat> <patientbirthdate>20060118</patientbirthdate> <patientonsetage/><patientonsetageunit/> <gestationperiod/> <gestationperiodunit/> <patientagegroup/> <patientweight/> <patientheight/> <patientsex>1</patientsex> <lastmenstrualdateformat/> <patientlastmenstrualdate/> <patientmedicalhistorytext></patientmedicalhistorytext> <resultstestsprocedures/> <patientdeath> <patientdeathdateformat/> <patientdeathdate/> <patientautopsyyesno/> </patientdeath> <reaction> <primarysourcereaction> Severe, </primarysourcereaction> <reactionmeddraversionllt>23.0</reactionmeddraversionllt> <reactionmeddrallt>Swelling</reactionmeddrallt> <reactionmeddraversionpt/> <reactionmeddrapt/> <termhighlighted/> <reactionstartdateformat>102</reactionstartdateformat><reactionstartdate>20240524</reactionstartdate> <reactionenddateformat/> <reactionenddate/> <reactionduration/> <reactiondurationunit/> <reactionfirsttime/> <reactionfirsttimeunit/> <reactionlasttime/> <reactionlasttimeunit/> <reactionoutcome>1</reactionoutcome> </reaction> <drug> <drugcharacterization>1</drugcharacterization> <medicinalproduct>Bivalent oral Polio vaccine</medicinalproduct> <obtaindrugcountry/> <drugbatchnumb>4444444</drugbatchnumb> <drugauthorizationnumb/> <drugauthorizationcountry/> <drugauthorizationholder/> <drugstructuredosagenumb>1</drugstructuredosagenumb> <drugstructuredosageunit><pre class="cake-error"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr6654598d02eb4-trace').style.display = (document.getElementById('cakeErr6654598d02eb4-trace').style.display == 'none' ? '' : 'none');"><b>Notice</b> (8)</a>: Undefined variable: sadrListOfDrug [<b>APP/View/Aefis/xml/download_r2.ctp</b>, line <b>260</b>]<div id="cakeErr6654598d02eb4-trace" class="cake-stack-trace" style="display: none;"><a href="javascript:void(0);" onclick="document.getElementById('cakeErr6654598d02eb4-code').style.display = (document.getElementById('cakeErr6654598d02eb4-code').style.display == 'none' ? '' : 'none')">Code</a> <a href="javascript:void(0);" onclick="document.getElementById('cakeErr6654598d02eb4-context').style.display = (document.getElementById('cakeErr6654598d02eb4-context').style.display == 'none' ? '' : 'none')">Context</a><pre id="cakeErr6654598d02eb4-code" class="cake-code-dump" style="display: none;"><code><span style="color: #000000">                <drugstructuredosagenumb><span style="color: #0000BB"><?php </span><span style="color: #007700">echo </span><span style="color: #0000BB">$listOfVaccine</span><span style="color: #007700">[</span><span style="color: #DD0000">'dosage'</span><span style="color: #007700">]; </span><span style="color: #0000BB">?></span></drugstructuredosagenumb></span></code> <code><span style="color: #000000">                <drugstructuredosageunit><?php</span></code> <span class="code-highlight"><code><span style="color: #000000"><span style="color: #0000BB">                    </span><span style="color: #007700">echo </span><span style="color: #0000BB">$sadrListOfDrug</span><span style="color: #007700">[</span><span style="color: #DD0000">'Dose'</span><span style="color: #007700">][</span><span style="color: #DD0000">'icsr_code'</span><span style="color: #007700">];</span></span></code></span></pre><pre id="cakeErr6654598d02eb4-context" class="cake-context" style="display: none;">$viewFile = '/var/www/pvers/app/View/Aefis/xml/download_r2.ctp' $dataForView = array( 'debugToolbarPanels' => array( 'history' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'history_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'session' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'session_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'request' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'request_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'sql_log' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'sql_log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'timer' => array( 'content' => null, 'elementName' => 'timer_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'log' => array( 'content' => object(DebugKitLog) {}, 'elementName' => 'log_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'variables' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'variables_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'environment' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'environment_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'include' => array( 'content' => array( [maximum depth reached] ), 'elementName' => 'include_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ) ), 'debugToolbarJavascript' => array( 'libs' => 'DebugKit./js/js_debug_toolbar' ), 'debugToolbarCss' => array( (int) 0 => 'DebugKit./css/debug_toolbar.css' ), 'aefi' => array( 'Aefi' => array( 'id' => '1663', 'user_id' => '9282', 'pqmp_id' => null, 'reference_no' => 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[maximum depth reached] ) ), 'elementName' => 'environment_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ), 'include' => array( 'content' => array( 'core' => array( [maximum depth reached] ), 'app' => array( [maximum depth reached] ), 'plugins' => array( [maximum depth reached] ), 'paths' => array( [maximum depth reached] ) ), 'elementName' => 'include_panel', 'plugin' => 'DebugKit', 'title' => null, 'disableTimer' => true ) ) $debugToolbarJavascript = array( 'libs' => 'DebugKit./js/js_debug_toolbar' ) $debugToolbarCss = array( (int) 0 => 'DebugKit./css/debug_toolbar.css' ) $aefi = array( 'Aefi' => array( 'id' => '1663', 'user_id' => '9282', 'pqmp_id' => null, 'reference_no' => 'AEFI/2024/22', 'aefi_id' => null, 'county_id' => '42', 'sub_county_id' => '237', 'vigiflow_ref' => null, 'vigiflow_date' => null, 'vigiflow_message' => null, 'webradr_ref' => null, 'webradr_date' => null, 'webradr_message' => null, 'designation_id' => '6', 'report_type' => 'Initial', 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'created' => '2012-06-15 10:27:02', 'modified' => '2012-06-15 10:27:02' ), 'SubCounty' => array( 'id' => '237', 'county_id' => '42', 'sub_county_name' => 'KISUMU EAST', 'county_name' => 'Kisumu', 'Province' => 'NYANZA', 'Pop_2009' => '150124', 'RegVoters' => '55267', 'AreaSqKms' => '136', 'CAWards' => '5', 'MainEthnicGroup' => 'LUO', 'created' => null, 'modified' => null ), 'Designation' => array( 'id' => '6', 'name' => 'Physician', 'category' => '1', 'created' => null, 'modified' => '2021-02-27 17:50:26' ), 'AefiOriginal' => array( 'id' => null, 'user_id' => null, 'pqmp_id' => null, 'reference_no' => null, 'aefi_id' => null, 'county_id' => null, 'sub_county_id' => null, 'vigiflow_ref' => null, 'vigiflow_date' => null, 'vigiflow_message' => null, 'webradr_ref' => null, 'webradr_date' => null, 'webradr_message' => null, 'designation_id' => null, 'report_type' => null, 'name_of_institution' => null, 'institution_code' => null, 'patient_name' => null, 'guardian_name' => null, 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'reporter_date' => null, 'submitted' => null, 'submitted_date' => null, 'active' => null, 'device' => null, 'copied' => null, 'archived' => null, 'archived_date' => null, 'deleted' => null, 'deleted_date' => null, 'created' => null, 'modified' => null, 'person_submitting' => null, 'reporter_name_diff' => null, 'reporter_designation_diff' => null, 'reporter_email_diff' => null, 'reporter_phone_diff' => null, 'reporter_date_diff' => null, 'assigned_to' => null, 'assigned_by' => null, 'assigned_date' => null, 'AefiOriginal' => array() ), 'AefiDescription' => array( (int) 0 => array( 'id' => '1663', 'aefi_id' => '1663', 'description' => 'Swelling', 'created' => '2024-05-27 11:21:49', 'modified' => '2024-05-27 11:59:49' ), (int) 1 => array( 'id' => '1663', 'aefi_id' => '1663', 'description' => 'Severe', 'created' => '2024-05-27 11:21:49', 'modified' => '2024-05-27 11:59:49' ) ), 'Attachment' => array(), 'AefiListOfVaccine' => array( (int) 0 => array( 'id' => '922', 'aefi_id' => '1663', 'saefi_id' => null, 'vaccine_id' => '14', 'vaccine_name' => '', 'vaccination_date' => '24-05-2024', 'vaccination_time' => array( [maximum depth reached] ), 'vaccine_manufacturer' => 'KKKTTTR', 'vaccination_route' => 'Intramuscular', 'vaccination_site' => 'left arm', 'dosage' => '1', 'icsr_code' => null, 'batch_number' => '4444444', 'expiry_date' => '27-05-2025', 'diluent_batch_number' => 'N/A', 'diluent_manufacturer' => 'YYYYY', 'diluent_expiry_date' => '19-05-2025', 'suspected_drug' => null, 'created' => '2024-05-27 11:56:22', 'modified' => '2024-05-27 11:59:49', 'Vaccine' => array( [maximum depth reached] ) ) ), 'ExternalComment' => array() ) $root = '/' $redir = 'manager' $arr = array( (int) 0 => 'Christine', (int) 1 => '' ) $birthdatef = (int) 102 $outcomes = array( 'Recovered/Resolved' => (int) 1, 'Recovering/Resolving' => (int) 2, 'Recovered/Resolved with sequelae' => (int) 3, 'Not recovered/Not resolved/Ongoing' => (int) 4, 'Fatal' => (int) 5, 'Unknown' => (int) 6 ) $listOfVaccine = array( 'id' => '922', 'aefi_id' => '1663', 'saefi_id' => null, 'vaccine_id' => '14', 'vaccine_name' => '', 'vaccination_date' => '24-05-2024', 'vaccination_time' => array( 'hour' => '12', 'min' => '20' ), 'vaccine_manufacturer' => 'KKKTTTR', 'vaccination_route' => 'Intramuscular', 'vaccination_site' => 'left arm', 'dosage' => '1', 'icsr_code' => null, 'batch_number' => '4444444', 'expiry_date' => '27-05-2025', 'diluent_batch_number' => 'N/A', 'diluent_manufacturer' => 'YYYYY', 'diluent_expiry_date' => '19-05-2025', 'suspected_drug' => null, 'created' => '2024-05-27 11:56:22', 'modified' => '2024-05-27 11:59:49', 'Vaccine' => array( 'id' => '14', 'vaccine_name' => 'Bivalent oral Polio vaccine', 'description' => 'Liquid Suspension - 20 doses per vial', 'health_program' => 'National Vaccines and immunisation program', 'created' => '2021-02-01 11:44:27', 'modified' => '2021-02-01 11:44:27', 'deleted' => false, 'deleted_date' => null ) ) $num = (int) 0</pre><pre class="stack-trace">include - APP/View/Aefis/xml/download_r2.ctp, line 260 View::_evaluate() - CORE/Cake/View/View.php, line 971 View::_render() - CORE/Cake/View/View.php, line 933 View::render() - CORE/Cake/View/View.php, line 473 XmlView::render() - CORE/Cake/View/XmlView.php, line 105 Controller::render() - CORE/Cake/Controller/Controller.php, line 968 AefisController::download() - APP/Controller/AefisController.php, line 1383 ReflectionMethod::invokeArgs() - [internal], line ?? Controller::invokeAction() - CORE/Cake/Controller/Controller.php, line 499 Dispatcher::_invoke() - CORE/Cake/Routing/Dispatcher.php, line 193 Dispatcher::dispatch() - CORE/Cake/Routing/Dispatcher.php, line 167 [main] - APP/webroot/index.php, line 118</pre></div></pre></drugstructuredosageunit> <drugseparatedosagenumb/> <drugintervaldosageunitnumb/> <drugintervaldosagedefinition/> <drugcumulativedosagenumb/> <drugcumulativedosageunit/> <drugdosagetext>1</drugdosagetext> <drugdosageform/> <drugadministrationroute/> <drugparadministration/> <reactiongestationperiod/> <reactiongestationperiodunit/> <drugindicationmeddraversion/> <drugindication/> <drugstartdateformat>102</drugstartdateformat> <drugstartdate>20240524</drugstartdate> <drugstartperiod/> <drugstartperiodunit/> <druglastperiod/> <druglastperiodunit/> <drugenddateformat/> <drugenddate/> <drugtreatmentduration/> <drugtreatmentdurationunit/> <actiondrug/> <drugrecurreadministration/> <drugadditional>N/A</drugadditional> <activesubstance> <activesubstancename></activesubstancename> </activesubstance> <drugreactionrelatedness> <drugreactionassesmeddraversion>23.0</drugreactionassesmeddraversion> <drugreactionasses>Swelling</drugreactionasses> <drugassessmentsource/> <drugassessmentmethod/> <drugresult/> </drugreactionrelatedness> </drug> <summary> <narrativeincludeclinical>Swelling of feet.</narrativeincludeclinical> <reportercomment/> <senderdiagnosismeddraversion>23.0</senderdiagnosismeddraversion> <senderdiagnosis></senderdiagnosis> <sendercomment/> </summary> </patient> </safetyreport> </ichicsr>
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    • 4(array)
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      • e2b_content<?xml version="1.0" encoding="UTF-8"?> <!DOCTYPE ichicsr SYSTEM "http://eudravigilance.ema.europa.eu/dtd/icsr21xml.dtd"> <ichicsr lang="en"> <ichicsrmessageheader lang="en"> <messagetype>ichicsr</messagetype> <messageformatversion>2.1</messageformatversion> <messageformatrelease>2.0</messageformatrelease> <messagenumb>KE-PPB-2024-14299</messagenumb> <messagesenderidentifier>PPB</messagesenderidentifier> <messagereceiveridentifier>KE</messagereceiveridentifier> <messagedateformat>204</messagedateformat> <messagedate>20240527105744</messagedate> </ichicsrmessageheader> <safetyreport lang="en"> <safetyreportversion>1</safetyreportversion> <safetyreportid>KE-PPB-AEFI/2023/6479</safetyreportid> <primarysourcecountry>KE</primarysourcecountry> <occurcountry>KE</occurcountry> <transmissiondateformat/> <transmissiondate/> <reporttype>1</reporttype> <serious>1</serious> <seriousnessdeath>2</seriousnessdeath> <seriousnesslifethreatening>2</seriousnesslifethreatening> <seriousnesshospitalization>2</seriousnesshospitalization> <seriousnessdisabling>2</seriousnessdisabling> <seriousnesscongenitalanomali>2</seriousnesscongenitalanomali> <seriousnessother>2</seriousnessother> <receivedateformat>102</receivedateformat> <receivedate>20231121</receivedate> <receiptdateformat>102</receiptdateformat> <receiptdate>20231121</receiptdate> <additionaldocument>2</additionaldocument> <documentlist></documentlist> <fulfillexpeditecriteria>2</fulfillexpeditecriteria> <authoritynumb>KE-PPB-AEFI/2023/6479</authoritynumb> <companynumb/> <duplicate/> <casenullification/> <nullificationreason/> <medicallyconfirm>1</medicallyconfirm> <primarysource> <reportergivename>Muthoni</reportergivename> <reporterfamilyname>Nyaga </reporterfamilyname> <reporterorganization>Kinoo Dispensary</reporterorganization> <reporterdepartment/> <reporterstreet/> <reportercity/> <reporterstate/> <reporterpostcode/> <reportercountry>KE</reportercountry> <qualification>2</qualification> <literaturereference/> <studyname/> <sponsorstudynumb/> <observestudytype/> </primarysource> <sender> <sendertype>3</sendertype> <senderorganization>Pharmacy and Poisons Board</senderorganization> <senderdepartment>Department of Pharmacovigilance</senderdepartment> <sendertitle>Dr.</sendertitle> <sendergivename>Christabel</sendergivename> <sendermiddlename>N.</sendermiddlename> <senderfamilyname>Khaemba</senderfamilyname> <senderstreetaddress>P.O. Box:27663-00506</senderstreetaddress> <sendercity>Nairobi</sendercity> <senderstate/> <senderpostcode>00506</senderpostcode> <sendercountrycode>KE</sendercountrycode> <sendertel>720608811</sendertel> <sendertelextension/> <sendertelcountrycode>254</sendertelcountrycode> <senderfax>2713409</senderfax> <senderfaxextension>20</senderfaxextension> <senderfaxcountrycode>254</senderfaxcountrycode> <senderemailaddress>pv@pharmacyboardkenya.org</senderemailaddress> </sender> <receiver> <receivertype/> <receiverorganization/> <receiverdepartment/> <receivertitle/> <receivergivename/> <receivermiddlename/> <receiverfamilyname/> <receiverstreetaddress/> <receivercity/> <receiverstate/> <receiverpostcode/> <receivercountrycode/> <receivertel/> <receivertelextension/> <receivertelcountrycode/> <receiverfax/> <receiverfaxextension/> <receiverfaxcountrycode/> <receiveremailaddress/> </receiver> <patient> <patientinitial>M A A</patientinitial> <patientgpmedicalrecordnumb></patientgpmedicalrecordnumb> <patientspecialistrecordnumb></patientspecialistrecordnumb> <patienthospitalrecordnumb></patienthospitalrecordnumb> <patientinvestigationnumb/> <patientbirthdateformat>602</patientbirthdateformat> <patientbirthdate></patientbirthdate> <patientonsetage>6</patientonsetage><patientonsetageunit>802</patientonsetageunit> <gestationperiod/> <gestationperiodunit/> <patientagegroup/> <patientweight/> <patientheight/> <patientsex>1</patientsex> <lastmenstrualdateformat/> <patientlastmenstrualdate/> <patientmedicalhistorytext></patientmedicalhistorytext> <resultstestsprocedures/> <patientdeath> <patientdeathdateformat/> <patientdeathdate/> <patientautopsyyesno/> </patientdeath> <reaction> <primarysourcereaction> Fever, </primarysourcereaction> <reactionmeddraversionllt>23.0</reactionmeddraversionllt> <reactionmeddrallt>Fontanelle bulging</reactionmeddrallt> <reactionmeddraversionpt/> <reactionmeddrapt/> <termhighlighted/> <reactionstartdateformat>102</reactionstartdateformat><reactionstartdate>20230901</reactionstartdate> <reactionenddateformat/> <reactionenddate/> <reactionduration/> <reactiondurationunit/> <reactionfirsttime/> <reactionfirsttimeunit/> <reactionlasttime/> <reactionlasttimeunit/> <reactionoutcome>1</reactionoutcome> </reaction> <drug> <drugcharacterization>1</drugcharacterization> <medicinalproduct>Novel oral polio vaccine type 2 (nOPV2)</medicinalproduct> <obtaindrugcountry/> <drugbatchnumb>22214222</drugbatchnumb> <drugauthorizationnumb/> <drugauthorizationcountry/> <drugauthorizationholder/> <drugstructuredosagenumb>1</drugstructuredosagenumb> <drugstructuredosageunit></drugstructuredosageunit> <drugseparatedosagenumb/> <drugintervaldosageunitnumb/> <drugintervaldosagedefinition/> <drugcumulativedosagenumb/> <drugcumulativedosageunit/> <drugdosagetext>1</drugdosagetext> <drugdosageform/> <drugadministrationroute/> <drugparadministration/> <reactiongestationperiod/> <reactiongestationperiodunit/> <drugindicationmeddraversion/> <drugindication/> <drugstartdateformat>102</drugstartdateformat> <drugstartdate>20230827</drugstartdate> <drugstartperiod/> <drugstartperiodunit/> <druglastperiod/> <druglastperiodunit/> <drugenddateformat/> <drugenddate/> <drugtreatmentduration/> <drugtreatmentdurationunit/> <actiondrug/> <drugrecurreadministration/> <drugadditional>10104723</drugadditional> <activesubstance> <activesubstancename></activesubstancename> </activesubstance> <drugreactionrelatedness> <drugreactionassesmeddraversion>23.0</drugreactionassesmeddraversion> <drugreactionasses>Fontanelle bulging</drugreactionasses> <drugassessmentsource/> <drugassessmentmethod/> <drugresult/> </drugreactionrelatedness> </drug> <summary> <narrativeincludeclinical>Infant was taken to Gertrude’s hospital after developing a bulging fontanelle for 6 days after oral polio vaccination. Parent noted the same bulging after vitamin A administration however resolved. </narrativeincludeclinical> <reportercomment/> <senderdiagnosismeddraversion>23.0</senderdiagnosismeddraversion> <senderdiagnosis></senderdiagnosis> <sendercomment/> </summary> </patient> </safetyreport> </ichicsr>
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      • descriptionsample
      • created2024-05-29 10:08:54
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  • StudyRoute(array)
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      • study_routeoral
      • created2024-02-22 01:39:23
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  • Manufacturer(array)
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      • manufacturing_activitiesPartial manufacturing
      • other_specify
      • created2024-02-22 01:39:23
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  • Reassignment(empty)
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      • checksum21396b2459a42bb0b29bc49fb8a5e374
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      • grouptest 15th
      • descriptiontest 15th files
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      • pocket_nametest 15th
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      • created2024-03-06 18:52:57
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      • pathimg/arms_7.png
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  • Reminder(empty)
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  • Deviation(array)
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      • deviation_date(null)
      • participant_number(null)
      • treating_physician(null)
      • deviation_description(null)
      • deviation_explanation(null)
      • deviation_measures(null)
      • deviation_preclude(null)
      • sponsor_notified0
      • sponsor_notification_date(null)
      • sponsor_explanation(null)
      • study_impact(null)
      • statusUnsubmitted
      • date_submitted(null)
      • deleted0
      • deleted_date(null)
      • created2024-05-23 22:33:01
      • modified2024-05-23 22:33:01
    • 7(array)
      • id19
      • application_id7
      • user_id53
      • reference_noDEV/2024/19
      • study_title<p> gjhsghjGHJGHJ</p>
      • deviation_type(null)
      • deviation_type_dev(null)
      • pi_namegiven faammma
      • deviation_date(null)
      • participant_number(null)
      • treating_physician(null)
      • deviation_description(null)
      • deviation_explanation(null)
      • deviation_measures(null)
      • deviation_preclude(null)
      • sponsor_notified0
      • sponsor_notification_date(null)
      • sponsor_explanation(null)
      • study_impact(null)
      • statusUnsubmitted
      • date_submitted(null)
      • deleted0
      • deleted_date(null)
      • created2024-05-29 10:07:42
      • modified2024-05-29 10:07:42
  • 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)
• redir
• $request->data(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • Review(empty)
  • InternalReview(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