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(1)衛生福利部食品藥物管理署 ICH E2B(R3)藥品不良反應通報系統測試. 操作手冊. 1.

(2) 目錄 壹、. 系統使用說明 ........................................................................................... 3. 一、 二、 三、 四、 五、. 系統測試網址 ........................................................................................... 3 本系統建議開啟方式 ............................................................................... 3 測試時間.................................................................................................... 3 如何申請帳號 ........................................................................................... 3 帳號角色及功能 ....................................................................................... 6 (一) 管理者帳號 ......................................................................................... 6 (二) 一般使用者帳號 ................................................................................. 7. 六、. 通報案件方式 ........................................................................................... 8 (一) 如何通報案件 ..................................................................................... 8 (二) 如何查詢通報過案件 ....................................................................... 13 (三) 通報案件內容有誤可以修改嗎 ....................................................... 15. 七、 八、. E2B R3 參考範例 ................................................................................... 17 E2B R3 批次上傳操作 ........................................................................... 20. 貳、 一、 二、. 相關資訊.................................................................................................. 23 系統網址: ................................................................................................ 23 技術服務聯絡資訊: ................................................................................ 23. 參、. 意見回饋單 ............................................................................................. 24. 肆、. 附件.......................................................................................................... 25. 一、 二、. 管理者帳號申請辦法暨權責聲明及申請資料表 ................................. 25 E2B R3 參考範例檔 ............................................................................... 28. 2.

(3) 壹、. 系統使用說明. 一、系統測試網址 https://e2badr.fda.gov.tw/。. 二、本系統建議開啟方式 以 Google chrome/Mozilla Firefox/Microsoft Edge/Apple Safari 等瀏覽器開 啟。. 三、測試時間 自 109 年 6 月 1 日至 6 月 30 日止,測試時間結束後將會將其帳號密碼及通 報資料全數刪除。正式資料請至現行系統(https://adr.fda.gov.tw)進行通報。. 四、如何申請帳號 (一) 首次使用本系統,需先註冊帳號,並填寫相關資料(黃底處為必填)。填 寫完畢後按下送出申請後,如成功會跳出對話框,同時使用者電子郵件 信箱會收到一封預設密碼的郵件。. (二) 帳號欄位說明: 1.. 登入帳號:該帳號必須為唯一,如有重複帳號,系統會在送出申請 3.

(4) 後顯示錯誤。 2.. 顯示名稱:此僅為登入畫面後之暱稱。. 3.. 電子郵件:請填寫可用之電子郵件,以利接收通報中心與您聯繫所 有與通報相關事務之用(包含收件回函、退件通知、資料異動通知 等),請確認您使用的信箱將不會將通報中心伺服器寄送之郵件偵 測為垃圾郵件。. 4.. 使用者姓:可填寫中英文,惟請填寫真實姓名,以利後續如需與之 聯繫使用。. 5.. 使用者名:可填寫中英文,惟請填寫真實姓名,以利後續如需與之 聯繫使用。. 6.. 使用者電話: 請填寫上班時間可聯絡的固定市內電話號碼及分機 號碼;若無固定電話者請填寫可聯絡的電話號碼。以利後續聯繫通 報相關事宜使用。. 7.. 人員屬性:請填寫使用者屬性,如醫師、藥師、其他醫療人員等並 勾選相關醫事機構,若勾選其他者亦請填寫醫事機構或相關單位。. 8.. 醫事機構: 請填寫所屬服務機構之名稱,得搜尋內建醫事機構資料 庫選取,服務機構名稱選定後會自動帶入地址。. 4.

(5) (三) 首次以預設密碼登入時,系統會自動要求變更密碼,輸入完成後按下送 出申請。. 密碼設定原則. 5.

(6) 五、帳號角色及功能 系統測試期間並未開放此功能,僅先供使用者瞭解未來帳號角色及功能。該 功能於日後正式上線時將以下列方式進行申請,並將視後續情況進行調整。. (一) 管理者帳號 1.. 一個單位僅能申請 1 組管理者帳號,一般使用者帳號上限為 4 組, 惟請依實際需求申請。. 2.. 醫療機構及藥商:請以醫療機構或公司名義連同「管理者帳號申請 辦法暨權責聲明及申請資料(如附件 1)」表正式行文至全國藥物不 良反應通報中心或本署。本署或委辦單位將依所提供資料於本系統 建立管理者帳號。. 3.. 帳號申請規則: 「醫療機構或公司英文簡稱+ 阿拉伯數字」 (如 TDRF01 ) ,新申請帳號之 E-mail 不得與其他通報帳號重複。藥 商申請時其名稱需與藥品許可證上之「申請商名稱 」一致 ,方可 收到系統副知的不良反應通報案件。. 4.. 帳號啟用: 系統將自動發送啟動密碼至電子郵件地址,並另行以 E-mail 通知,故請確實填寫申請表資料。使用者收到啟動密碼後, 請依其帳號及所提供之啟動密碼登入系統,進入系統基本資料修改 功能,將相關資料填齊,並修改登入密碼。. 5.. 管理權責須知: (1) 帳號管理及使用權責由各單位自行負責。 (2) 帳號密碼應由各單位及其系統使用者本人妥善保存,並在人員 或職務異動時自行交接並於系統上更新相關資料(包含密 碼)。 (3) 每三個月會提醒更新密碼,並請同時確認基本資料是否須更新, 以保障其使用之權益,敬請配合。 6.

(7) 6.. 功能權限: (1) 可進行案件通報。 (2) 得以查看及編輯該單位內所有使用者通報的案件。 (3) 得以執行該單位內一般使用者帳號重啟或暫停,及檢視上線使 用者情形。 (4) 得於系統即時維護該單位資訊,包含:食品藥物管理署與藥商 之緊急連絡使用資訊、醫療機構資訊維護、收到系統副知通報 表資訊之副知窗口(Email)等。. (二) 一般使用者帳號 1.. 帳號申請規則:請參照「如何申請帳號」。. 2.. 權責須知: (1) 該等帳號密碼應妥善保存,並在人員或職務異動時自行交接並 於系統上更新相關資料(包含密碼)。 (2) 每三個月會提醒更新密碼,並請同時確認基本資料是否須更新, 以保障其使用之權益,敬請配合。. 3.. 功能權限: (1) 可進行案件通報。 (2) 可搜尋該帳號通報過之案件。. 7.

(8) 六、. 通報案件方式. (一) 如何通報案件 1. 針對單一案件之線上通報者:在登入系統後,進入案件列表,點選「通 報上市後藥品新案件」 、 「通報臨床試驗藥品新案件」 ,即出現對話框, 選取通報項目,即可進入案件通報編輯頁面。. 8.

(9) 通報過程中如需暫存,請直接按暫存鍵,會出現下列提醒未填寫處, 按下了解鍵後,即可登出或回到列表頁。回到列表處可看見未出送 案件,並可以使用列印模式,了解填寫情形,如需繼續填寫,點選 上市藥品一般通報案件,即回到填寫畫面可繼續填寫。. 9.

(10) 填寫過程如有錯誤或必填卻未填寫處,暫存時皆會出現提醒,亦無 法送出該案件。. 10.

(11) 2. 針對以 E2B R3 格式做批次上傳者:在登入系統後點選「批次上傳案 件」 ,進入頁面後選取「上傳藥物批次案件」或「上傳臨床試驗批次 案件」。. 選擇上傳的檔案(.zip 或.xml)後,如果上傳檔案符合 E2B R3 規範,則系 統會自動轉譯檔案內容如下圖供上傳者檢視。. 11.

(12) 一旦檢視無誤,則按下送出鍵,則該案件即自動送出,使用者可至案件 管理中檢視送出的案件。. 12.

(13) (二) 如何查詢通報過案件 進入案件管理頁面,案件分為未送出及已送出,未送出之案件可允許使 用者修改,已送出案件則無法修改。每一案件均可自行列印下載成 PDF 檔,如下。. 13.

(14) 14.

(15) (三) 通報案件內容有誤可以修改嗎 1. 點擊未送出之案件點選案件屬性則會自動跳入編輯頁面,使用者可 以在此繼續編輯。. 2. 針對已送出案件如有需要更正或補充資料,則需以案件追蹤進行, 按下案件追蹤,則會將此案件內容複製至同一案件編號之未送出新 案件,供使用者編輯。. 15.

(16) 將自動帶入原有案件內容資料,新 增資訊過程中亦可進行暫存。. 16.

(17) 七、. E2B R3 參考範例. (一) 本系統係為依據 ICH E2B (R3)格式中有關不良反應資料交換定義所建 構而來。標準命名為「ISO / HL7 27953-2: 2011 Health informatics -Individual case safety reports (ICSRs) in pharmacovigilance -- Part 2: Human pharmaceutical reporting requirements for ICSR」 ,參考範例如附件 2,詳請自行至 ISO 網站參閱(http://www.iso.org/iso/store.htm)。ICH ICSR 關聯架構及上傳資料格式架構說明如下:. (二) TFDA 通報表與 ICH E2B R3 關聯資料對照如下: TFDA 資料欄位. ICH E2B(R3)對應欄位. 資料型態. 發生日期. E.i.4 - Date of Start of Reaction / Event. 日期. 通報者獲知日期. C.1.4 - Date Report Was First Received from Source. 日期. 17. 備註.

(18) 是否國內案件. 無. 文數字. 客製欄位. 原始藥物不良反 應獲知來源. 無. 文數字. 客製欄位. 文獻通報. 無. 文數字. 客製欄位. 識別代碼. D.1.1.2 - Patient Medical Record Number(s) and the Source(s) of the Record Number (Specialist Record Number). 文數字. 原通報單位識別 代號. D.1.1.3 - Patient Medical Record Number(s) and the Source(s) of the Record Number (Hospital. 文數字. Record Number) 性別. D.5 - Sex. 文數字. 出生日期. D.2.1 - Date of Birth. 日期. 首次發生不良反 應年齡. D.2.2a/D.2.2b - Age at Time of Onset of Reaction / Event. 數字. 大約年齡. D.2.3 - Patient Age Group (as per reporter). 文數字. 體重(kg). D.3 - Body Weight (kg). 數字. 身高(cm). D.4 - Height (cm). 數字. 不良事件結果. E.i.3.2 - Seriousness Criteria at Event Level. 文數字. 死亡日期. D.9.1 - Date of Death. 日期. 死亡原因. D.9.2.r.2 - Reported Cause(s) of Death (free text). 文數字. 案件描述. 文數字. 檢驗說明. H.1 - Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information 無. 其他相關資料. H.2 - Reporter’s comments. 文數字. 不良事件後續結. E.i.7 - Outcome of Reaction /. 文數字. 果. Event at the Time of Last Observation. 不良反應症狀. E.i.1.1a - Reaction / Event as Reported by the Primary Source in Native Language. 文數字. 檢驗日期. F.r.1 - Test Date. 日期 18. 文數字. 客製欄位.

(19) 檢驗項目. F.r.2.1 - Test Name (free text). 文數字. 檢驗結果. F.r.3.2 - Test Result (value/qualifier). 文數字. 檢驗結果單位. F.r.3.3 - Test Result (unit). 文數字. 檢查描述. F.r.3.4 - Result Unstructured Data (free text). 文數字. 許可字號. G.k.3.1 - Authorisation / Application Number. 文數字. 學名. G.k.2.3.r.1 - Substance/ Specified Substance Name. 文數字. 商品名. G.k.2.2 - Medicinal Product Name 文數字 as Reported by the Primary Source. 廠商. G.k.3.3 - Name of Holder /. 文數字. Applicant 含量. G.k.2.3.r.3 - Strength (number). 數字. 含量單位. G.k.2.3.r.4 - Strength (unit). 文數字. 劑型 劑量. G.k.4.r.9.1 - Pharmaceutical Dose 文數字 Form (free text) 數字 G.k.4.r.1a - Dose (number). 劑量單位. G.k.4.r.1b - Dose (unit). 文數字. 頻率. G.k.4.r.2 - Number of Units in the. 數字. Interval 頻率單位. G.k.4.r.3 - Definition of the Time Interval Unit. 文數字. 起始日期. G.k.4.r.4 - Date and Time of Start of Drug. 日期. 結束日期. G.k.4.r.5 - Date and Time of Last Administration. 日期. 用藥原因. G.k.4.r.8 - Dosage Text. 文數字. 給藥途徑. G.k.4.r.10.1 - Route of Administration (free text). 文數字. 批號. 文數字. 效期. G.k.4.r.7 - Batch / Lot Number 無. 處置情形. G.k.8 - Action(s) Taken with Drug. 文數字. 再投藥是否出現 同樣反應. G.k.9.i.4 - Did Reaction Recur on Re-administration?. 文數字. 19. 文數字. 客製欄位.

(20) 八、. E2B R3 批次上傳操作. (一) 上傳檔案格式為符合 ICH E2B (R3)批次傳遞規範之.xml 檔或包含符合前述 規範之.xml 檔在內的.zip 壓縮檔。每一件不良反應案件需以表頭 <PORR_IN049016UV></PORR_IN049016UV>包覆。 (二) 如為.zip 壓縮檔,則壓縮檔內僅可內含一個批次.xml 檔,但一個批次檔 內可包含多個通報案件內容。 (三) 批次檔表頭須符合 R3 規範:. <?xml version="1.0" encoding="UTF-8"?> <MCCI_IN200100UV01 ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3 MCCI_IN200100UV01.xsd" xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"> <id extension="[ Batch Number]" root="2.16.840.1.113883.3.989.2.1.3.22"/> <creationTime value="[Date of Batch Transmission]"/> <responseModeCode code="D"/> <interactionId extension="MCCI_IN200100UV01" root="2.16.840.1.113883.1.6"/> <name code="[ Type of Messages in Batch]" codeSystem="2.16.840.1.113883.3.989.2.1.1.1"/> <PORR_IN049016UV> …..[單一案件訊息本體]….. </PORR_IN049016UV> <PORR_IN049016UV> …..[ 單一案件訊息本體]….. </PORR_IN049016UV> <receiver typeCode="RCV"> <device classCode="DEV" determinerCode="INSTANCE"> <id extension="[Batch Receiver Identifier]" root="2.16.840.1.113883.3.989.2.1.3.14"/> </device> </receiver> <sender typeCode="SND"> 20.

(21) <device classCode="DEV" determinerCode="INSTANCE"> <id extension="[Batch Sender Identifier]" root="2.16.840.1.113883.3.989.2.1.3.13"/> </device> </sender> </MCCI_IN200100UV01> (四) 目前系統並未提供 Batch Acknowledgement,但上傳檔案仍需遵循批次檔案 的表頭格式。 (五) 檔案上傳後,系統會自行一 R3 規範擷取所有案件資訊,並以頁簽方式分別 顯示個規範區塊之資訊。使用者檢核無誤後則可按送出鍵將案件送出。. (六) 如果批次檔中內含多個案件,則系統會分別萃取案件資料顯示如下,使用者 可個別案件逐一檢視資訊,待資訊無誤,則按送出即將所有案件一起送出。. 21.

(22) (七) R3 規範中規定之必填資訊必須存在,否則系統在檢核時會通報錯誤。 (八) 一但送出成功,則系統會賦予一個中心編號,使用者可以在案件管理列表之 送出頁簽中檢視。. 22.

(23) 貳、. 相關資訊. 一、. 系統網址: https://e2badr.fda.gov.tw/. 二、. 技術服務聯絡資訊: info@digigenomics.com,並副知 j81313@fda.gov.tw. 23.

(24) 參、. 意見回饋單. 問題 建議: 結論:. 姓名: 職稱. 24.

(25) 肆、. 附件. 一、管理者帳號申請辦法暨權責聲明及申請資料表. 25.

(26) 26.

(27) 27.

(28) 二、E2B R3 參考範例檔. 28.

(29) N.1. N.1.2. N.1.2. N.1. N.1.5. N.1.5. Batch Number Date of Batch Transmission. 2.1.3.22. <?xml version="1.0" encoding="UTF-8"?> <MCCI_IN200100UV01 ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3 MCCI_IN200100UV01.xsd" xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"> <id extension="N.1.2" root="2.16.840.1.113883.3.989.2.1.3.22"/> <creationTime value="20101214151617"/> <responseModeCode code="D"/> <interactionId extension="MCCI_IN200100UV01" root="2.16.840.1.113883.1.6"/>. N.1. N.1.1. N.1.1. Type of Messages in Batch. 2.1.1.1. <name code="N.1.1" codeSystem="2.16.840.1.113883.3.989.2.1.1.1" codeSystemVersion="1.01"/> <PORR_IN049016UV>. N.2. N.2.r.1. N.2.r.1. N.2. N.2.r.4. N.2.r.4. Message Identifier Date of Message Creation. 2.1.3.1. <id extension="N.2.r.1" root="2.16.840.1.113883.3.989.2.1.3.1"/> <creationTime value="20101214151617"/> <interactionId extension="PORR_IN049016UV" root="2.16.840.1.113883.1.6"/> <processingCode code="P"/> <processingModeCode code="T"/> <acceptAckCode code="AL"/>. N.2. N.2.r.3. N.2. N.2.r.3. <receiver typeCode="RCV">. N.2. N.2.r.3. N.2. N.2.r.3. </device>. N.2. N.2.r.3. </receiver>. N.2. N.2.r.2. <sender typeCode="SND">. N.2. N.2.r.2. N.2. N.2.r.2. N.2. N.2.r.2. N.2. N.2.r.2. <device classCode="DEV" determinerCode="INSTANCE"> N.2.r.3. Message Receiver Identifier. 2.1.3.12. <id extension="N.2.r.3" root="2.16.840.1.113883.3.989.2.1.3.12"/>. <device classCode="DEV" determinerCode="INSTANCE"> N.2.r.2. Message Sender Identifier. 2.1.3.11. <id extension="N.2.r.2" root="2.16.840.1.113883.3.989.2.1.3.11"/> </device> </sender> <controlActProcess classCode="CACT" moodCode="EVN">. HL7Trigger 2.16.840.1.11 EventID 3883.1.18 C. C.1.2. C.1.2. <code code="PORR_TE049016UV" codeSystem="2.16.840.1.113883.1.18"/> <effectiveTime value="20101214151617"/>. Date of Creation. <subject typeCode="SUBJ"> <investigationEvent classCode="INVSTG" moodCode="EVN"> C. C.1.1. C.1.1. C. C.1.8.1. C.1.8.1. H. H.1. C. C.1.4. H.1. Sender's (case) Safety Report Unique Identifier Worldwide Unique Case Identification Number. 2.1.3.1. <id extension="C.1.1" root="2.16.840.1.113883.3.989.2.1.3.1"/>. 2.1.3.2. <id extension="C.1.8.1" root="2.16.840.1.113883.3.989.2.1.3.2"/>. 2.16.840.1.11 3883.5.4. <code code="PAT_ADV_EVNT" codeSystem="2.16.840.1.113883.5.4"/>. Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant. <text>H.1</text>. <statusCode code="active"/>. C. C.1.4. C. C.1.4. C. C.1.5. <effectiveTime> C.1.4. Date Report Was First Received from Source. <low value="20090101"/> </effectiveTime>. C.1.5. Date of Most Recent Information for. <availabilityTime value="20090101"/>. C. C.1.6.1.r. R1. C.1.6.1.r.1, 2. C. C.1.6.1.r. R1. C.1.6.1.r.1, 2. <reference typeCode="REFR">. C. C.1.6.1.r. R1. C.1.6.1.r.1, 2. C. C.1.6.1.r. R1. C. C.1.6.1.r. R1. C. C.1.6.1.r. R1. Documents Held C.1.6.1.r.1, 2 C.1.6.1.r.1 by Sender (repeat as necessary) Included C.1.6.1.r.1, 2 C.1.6.1.r.2 Documents C.1.6.1r.1, 2. C. C.1.6.1.r. R1. C.1.6.1r.1, 2. </reference>. C. C.1.6.1.r. R2. C.1.6.1.r.1, 2. <reference typeCode="REFR">. <document classCode="DOC" moodCode="EVN"> 2.1.1.27. <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.27" codeSystemVersion="1.0" displayName="documentsHeldBySender"/> <title>C.1.6.1.r.1</title> <text mediaType="application/pdf" representation="B64">C.1.6.1.r.2</text> </document>.

(30) C C. C.1.6.1.r C.1.6.1.r. R2 R2. C.1.6.1.r.1, 2 C.1.6.1.r.1, 2. C. C.1.6.1.r. R2. C. C.1.6.1.r. R2. C. C.1.6.1.r. R2. Documents Held C.1.6.1.r.1, 2 C.1.6.1.r.1 by Sender (repeat as necessary) Included C.1.6.1.r.1, 2 C.1.6.1.r.2 Documents C.1.6.1.r.1, 2. C. C.1.6.1.r. R2. C.1.6.1.r.1, 2. </reference>. C. C.4.r. R1. C.4.r.1, 2. <reference typeCode="REFR">. C C. C.4.r C.4.r. R1 R1. C.4.r.1, 2 C.4.r.1, 2. C. C.4.r. R1. C.4.r.1, 2. C.4.r.2. C. C.4.r. R1. C.4.r.1, 2. C.4.r.1. C. C.4.r. R1. C.4.r.1, 2. C. C.4.r. R1. C.4.r.1, 2. </reference>. C. C.4.r. R2. C.4.r.1, 2. <reference typeCode="REFR">. C C. C.4.r C.4.r. R2 R2. C.4.r.1, 2 C.4.r.1, 2. C. C.4.r. R2. C.4.r.1, 2. C.4.r.2. C. C.4.r. R2. C.4.r.1, 2. C.4.r.1. C. C.4.r. R2. C.4.r.1, 2. C. C.4.r. R2. C.4.r.1, 2. 2.1.1.27. <document classCode="DOC" moodCode="EVN"> <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.27" codeSystemVersion="1.0" displayName="documentsHeldBySender"/> <title>C.1.6.1.r.1</title> <text mediaType="image/jpeg" representation="B64" compression="DF">C.1.6.1.r.2</text> </document>. 2.1.1.27. <document classCode="DOC" moodCode="EVN"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.27" codeSystemVersion="1.0" displayName="literatureReference"/> <text mediaType="application/pdf" representation="B64">C.4.r.2</text>. Included Documents Literature Reference(s). <bibliographicDesignationText>C.4.r.1</bibliographicDesignationText> </document>. 2.1.1.27. <document classCode="DOC" moodCode="EVN"> <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.27" codeSystemVersion="1.0" displayName="literatureReference"/> <text mediaType="application/pdf" representation="B64">C.4.r.2</text>. Included Documents Literature Reference(s). <bibliographicDesignationText>C.4.r.1</bibliographicDesignationText> </document> </reference> <component typeCode="COMP"> <adverseEventAssessment classCode="INVSTG" moodCode="EVN"> <subject1 typeCode="SBJ"> <primaryRole classCode="INVSBJ"> <player1 classCode="PSN" determinerCode="INSTANCE">. D. D.1. D.1. D D. D.5 D.2.1. D.5 D.2.1. Patient (name or initials) Sex Date of Birth. D. D.9.1. D.9.1. Date of Death. D. D.1.1.1. D.1.1.1. Patient Medical Record Number(s) and the Source(s) of the Record Number (GP Medical Record Number). D. D.1.1.1. D. D.1.1.1. D. D.1.1.1. D. D.1.1.2. D. D.1.1.2. D. D.1.1.2. D. D.1.1.2. D. D.1.1.3. D. D.1.1.3. D. D.1.1.3. D. D.1.1.3. D. D.1.1.4. D. D.1.1.4. <name>D.1</name> 1.0.5218. <administrativeGenderCode code="D.5" codeSystem="1.0.5218"/> <birthTime value="20090101"/> <deceasedTime value="20090101"/> <asIdentifiedEntity classCode="IDENT">. 2.1.3.7. 2.1.1.4. <id extension="D.1.1.1" root="2.16.840.1.113883.3.989.2.1.3.7"/>. <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.4" codeSystemVersion="1.0" displayName="GP"/> </asIdentifiedEntity> <asIdentifiedEntity classCode="IDENT">. D.1.1.2. Patient Medical Record Number(s) and the Source(s) of the Record Number (Specialist Record Number). 2.1.3.8. 2.1.1.4. <id extension="D.1.1.2" root="2.16.840.1.113883.3.989.2.1.3.8"/>. <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.4" codeSystemVersion="1.0" displayName="Specialist"/> </asIdentifiedEntity> <asIdentifiedEntity classCode="IDENT">. D.1.1.3. Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number). 2.1.3.9. 2.1.1.4. <id extension="D.1.1.3" root="2.16.840.1.113883.3.989.2.1.3.9"/>. <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.4" codeSystemVersion="1.0" displayName="Hospital Record"/> </asIdentifiedEntity> <asIdentifiedEntity classCode="IDENT">. D.1.1.4. Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation. 2.1.3.10. <id extension="D.1.1.4" root="2.16.840.1.113883.3.989.2.1.3.10"/>.

(31) D. D.1.1.4. D. D.1.1.4. 2.1.1.4. <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.4" codeSystemVersion="1.0" displayName="Investigation"/> </asIdentifiedEntity>. D.10. <role classCode="PRS"> 2.16.840.1.11 3883.5.111. D.10 D.10. <code code="PRN" codeSystem="2.16.840.1.113883.5.111"/> <associatedPerson classCode="PSN" determinerCode="INSTANCE">. D.10. D.10.1. D.10.1. D.10. D.10.6. D.10.6. D.10. D.10.2.1. D.10.2.1. <name>D.10.1</name>. Parent Identification Sex of Parent Date of Birth of Parent. 1.0.5218. <administrativeGenderCode code="D.10.6" codeSystem="1.0.5218"/> <birthTime value="20090101"/>. D.10. </associatedPerson>. D.10. D.10.2.2. D.10. D.10.2.2. <subjectOf2 typeCode="SBJ">. D.10. D.10.2.2. D.10. D.10.2.2. D.10. D.10.2.2. D.10. D.10.2.2. </subjectOf2>. D.10. D.10.3. <subjectOf2 typeCode="SBJ">. D.10. D.10.3. D.10. D.10.3. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.10.2.2a. Age of Parent (number). <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="age"/> <value xsi:type="PQ" value="10" unit="D.10.2.2b"/>. D.10.2.2b Age of Parent (unit). </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Last Menstrual Period Date of Parent. <code code="22" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="lastMenstrualPeriodDate"/>. D.10. D.10.3. D.10. D.10.3. D.10. D.10.3. </subjectOf2>. D.10. D.10.4. <subjectOf2 typeCode="SBJ">. D.10. D.10.4. D.10. D.10.4. D.10. D.10.4. D.10. D.10.4. D.10. D.10.4. </subjectOf2>. D.10. D.10.5. <subjectOf2 typeCode="SBJ">. D.10. D.10.5. D.10. D.10.5. D.10. D.10.5. D.10. D.10.5. D.10. D.10.5. D.10.3. <value xsi:type="TS" value="20090101"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.10.4. <code code="7" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="bodyWeight"/> <value xsi:type="PQ" value="50" unit="kg"/>. Body Weight (kg) of Parent. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.10.5. <code code="17" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="height"/> <value xsi:type="PQ" value="160" unit="cm"/>. Height (cm) of Parent. </observation> </subjectOf2>. D.10. <subjectOf2 typeCode="SBJ">. D.10. <organizer classCode="CATEGORY" moodCode="EVN">. D.10. 2.1.1.20. D.10. D.10.7.1.r R1. D.10. D.10.7.1.r R1. <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="1.0" displayName="relevantMedicalHistoryAndConcurrentConditions"/> <component typeCode="COMP"> <observation classCode="OBS" moodCode="EVN">. D.10. D.10.7.1.r R1. D.10. D.10.7.1.r R1. Medical History MedDRA Version (disease / surgical D.10.7.1.r.1b D.10.7.1.r.1 D.10.7.1.r.1a for Medical History procedure/ etc.) (MedDRA code) D.10.7.1.r.2, 4. D.10. D.10.7.1.r R1. D.10.7.1.r.2, 4D.10.7.1.r.2 Start Date. D.10. D.10.7.1.r R1. D.10.7.1.r.2, 4D.10.7.1.r.4 End Date. D.10. D.10.7.1.r R1. D.10.7.1.r.2, 4. </effectiveTime>. D.10. D.10.7.1.r R1. D.10.7.1.r.5. <outboundRelationship2 typeCode="COMP">. D.10. D.10.7.1.r R1. D.10.7.1.r.5. D.10. D.10.7.1.r R1. D.10.7.1.r.5. D.10. D.10.7.1.r R1. D.10.7.1.r.5 D.10.7.1.r.5 Comments. D.10. D.10.7.1.r R1. D.10.7.1.r.5. D.10. D.10.7.1.r R1. D.10.7.1.r.5. </outboundRelationship2>. D.10. D.10.7.1.r R1. D.10.7.1.r.3. <inboundRelationship typeCode="REFR">. D.10. D.10.7.1.r R1. D.10.7.1.r.3. D.10. D.10.7.1.r R1. D.10.7.1.r.3. D.10. D.10.7.1.r R1. D.10.7.1.r.3 D.10.7.1.r.3 Continuing. D.10. D.10.7.1.r R1. D.10.7.1.r.3. 2.16.840.1.11 3883.6.163. <code code="D.10.7.1.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.10.7.1.r.1a"/> <effectiveTime xsi:type="IVL_TS"> <low value="20090101"/> <high value="20090101"/>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19. <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="comment"/> <value xsi:type="ED">D.10.7.1.r.5</value> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19. <code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="continuing"/> <value xsi:type="BL" value="true"/> </observation>.

(32) D.10. D.10.7.1.r R1. D.10. D.10.7.1.r R1. D.10.7.1.r.3. </inboundRelationship>. D.10. D.10.7.1.r R1. </component>. D.10. D.10.7.1.r R2. <component typeCode="COMP">. D.10. D.10.7.1.r R2. </observation>. <observation classCode="OBS" moodCode="EVN">. D.10. D.10.7.1.r R2. D.10. D.10.7.1.r R2. Medical History MedDRA Version (disease / surgical D.10.7.1.r.1b D.10.7.1.r.1 D.10.7.1.r.1a for Medical History procedure/ etc.) (MedDRA code) D.10.7.1.r.2, 4. D.10. D.10.7.1.r R2. D.10.7.1.r.2, 4D.10.7.1.r.2 Start Date. D.10. D.10.7.1.r R2. D.10.7.1.r.2, 4D.10.7.1.r.4 End Date. D.10. D.10.7.1.r R2. D.10.7.1.r.2, 4. </effectiveTime>. D.10. D.10.7.1.r R2. D.10.7.1.r.5. <outboundRelationship2 typeCode="COMP">. D.10. D.10.7.1.r R2. D.10.7.1.r.5. D.10. D.10.7.1.r R2. D.10.7.1.r.5. D.10. D.10.7.1.r R2. D.10.7.1.r.5 D.10.7.1.r.5 Comments. D.10. D.10.7.1.r R2. D.10.7.1.r.5. D.10. D.10.7.1.r R2. D.10.7.1.r.5. </outboundRelationship2>. D.10. D.10.7.1.r R2. D.10.7.1.r.3. <inboundRelationship typeCode="REFR">. D.10. D.10.7.1.r R2. D.10.7.1.r.3. D.10. D.10.7.1.r R2. D.10.7.1.r.3. D.10. D.10.7.1.r R2. D.10.7.1.r.3 D.10.7.1.r.3 Continuing. D.10. D.10.7.1.r R2. D.10.7.1.r.3. D.10. D.10.7.1.r R2. D.10.7.1.r.3. D.10. D.10.7.1.r R2. D.10. D.10.7.1.r R2. 2.16.840.1.11 3883.6.163. <code code="D.10.7.1.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.10.7.1.r.1a"/> <effectiveTime xsi:type="IVL_TS"> <low value="20090101"/> <high value="20090101"/>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19. <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="comment"/> <value xsi:type="ED">D.10.7.1.r.5</value> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19. <code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="continuing"/> <value xsi:type="BL" value="true"/> </observation> </inboundRelationship> </observation> </component>. D.10. D.10.7.2. D.10. D.10.7.2. D.10. D.10.7.2. D.10. D.10.7.2. D.10. D.10.7.2. D.10. D.10.7.2. <component typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> 2.1.1.19. D.10.7.2. Text for Relevant Medical History and Concurrent Conditions of Parent. <code code="18" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="historyAndConcurrentConditionText"/>. <value xsi:type="ED">D.10.7.2</value>. </observation> </component>. D.10. </organizer>. D.10. </subjectOf2>. D.10. <subjectOf2 typeCode="SBJ">. D.10. <organizer classCode="CATEGORY" moodCode="EVN">. D.10. 2.1.1.20. <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="1.0" displayName="drugHistory"/>. D.10. D.10.8.r. R1. <component typeCode="COMP">. D.10. D.10.8.r. R1. D.10. D.10.8.r. R1. D.10.8.r.4, 5. D.10. D.10.8.r. R1. D.10.8.r.4, 5 D.10.8.r.4 Start Date. <low value="20090101"/>. D.10. D.10.8.r. R1. D.10.8.r.4, 5 D.10.8.r.5 End Date. <high value="20090101"/>. D.10. D.10.8.r. R1. D.10.8.r.4, 5. </effectiveTime>. D.10. D.10.8.r. R1. D.10.8.r.1, 2. <consumable typeCode="CSM">. D.10. D.10.8.r. R1. D.10.8.r.1, 2. D.10. D.10.8.r. R1. D.10.8.r.1, 2. D.10. D.10.8.r. R1. D.10.8.r.1, 2 D.10.8.r.2a. D.10. D.10.8.r. R1. D.10. D.10.8.r. R1. MPID Version Date / Number Name of Drug as D.10.8.r.1, 2 D.10.8.r.1 Reported D.10.8.r.1, 2. D.10. D.10.8.r. R1. D.10.8.r.1, 2. D.10. D.10.8.r. R1. D.10.8.r.1, 2. </consumable>. D.10. D.10.8.r. R1. D.10.8.r.6. <outboundRelationship2 typeCode="RSON">. D.10. D.10.8.r. R1. D.10.8.r.6. D.10. D.10.8.r. R1. D.10.8.r.6. D.10. D.10.8.r. R1. D.10.8.r.6. <substanceAdministration classCode="SBADM" moodCode="EVN"> <effectiveTime xsi:type="IVL_TS">. <instanceOfKind classCode="INST"> <kindOfProduct classCode="MMAT" determinerCode="KIND"> D.10.8.r.2b. Medicinal Product Identifier (MPID). TBD-MPID. <code code="D.10.8.r.2b" codeSystem="TBD-MPID" codeSystemVersion="D.10.8.r.2a"/> <name>D.10.8.r.1</name> </kindOfProduct> </instanceOfKind>. <observation classCode="OBS" moodCode="EVN">. D.10.8.r.6a. MedDRA Version for Indication. D.10.8.r.6b. Indication (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="indication"/> <value xsi:type="CE" code="D.10.8.r.6b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.10.8.r.6a"/>.

(33) D.10. D.10.8.r. R1. D.10.8.r.6. D.10. D.10.8.r. R1. D.10.8.r.6. </outboundRelationship2>. D.10. D.10.8.r. R1. D.10.8.r.7. <outboundRelationship2 typeCode="CAUS">. D.10. D.10.8.r. R1. D.10.8.r.7. D.10. D.10.8.r. R1. D.10.8.r.7. D.10. D.10.8.r. R1. D.10.8.r.7. D.10. D.10.8.r. R1. D.10.8.r.7. D.10. D.10.8.r. R1. D.10.8.r.7. D.10. D.10.8.r. R1. D.10. D.10.8.r. R1. </component>. D.10. D.10.8.r. R2. <component typeCode="COMP">. D.10. D.10.8.r. R2. D.10. D.10.8.r. R2. D.10.8.r.4, 5. D.10. D.10.8.r. R2. D.10.8.r.4, 5 D.10.8.r.4 Start Date. <low value="20090101"/>. D.10. D.10.8.r. R2. D.10.8.r.4, 5 D.10.8.r.5 End Date. <high value="20090101"/>. D.10. D.10.8.r. R2. D.10.8.r.4, 5. </effectiveTime>. D.10. D.10.8.r. R2. D.10.8.r.1, 2. <consumable typeCode="CSM">. D.10. D.10.8.r. R2. D.10.8.r.1, 2. D.10. D.10.8.r. R2. D.10.8.r.1, 2. R2. PhPID Version D.10.8.r.1, 2 D.10.8.r.3a Date / Number. D.10. D.10.8.r. </observation>. <observation classCode="OBS" moodCode="EVN">. D.10.8.r.7a. MedDRA Version for Reaction. D.10.8.r.7b. Reactions (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reaction"/> <value xsi:type="CE" code="D.10.8.r.7b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.10.8.r.7a"/> </observation> </outboundRelationship2> </substanceAdministration>. <substanceAdministration classCode="SBADM" moodCode="EVN"> <effectiveTime xsi:type="IVL_TS">. <instanceOfKind classCode="INST"> <kindOfProduct classCode="MMAT" determinerCode="KIND"> Pharmaceutical D.10.8.r.3b Product Identifier (PhPID). <code code="D.10.8.r.3b" codeSystem="TBD-PhPID" codeSystemVersion="D.10.8.r.3a"/>. TBD-PhPID. <name>D.10.8.r.1</name>. D.10. D.10.8.r. R2. D.10.8.r.1, 2 D.10.8.r.1. D.10. D.10.8.r. R2. D.10.8.r.1, 2. D.10. D.10.8.r. R2. D.10.8.r.1, 2. D.10. D.10.8.r. R2. D.10.8.r.1, 2. </consumable>. D.10. D.10.8.r. R2. D.10.8.r.6. <outboundRelationship2 typeCode="RSON">. D.10. D.10.8.r. R2. D.10.8.r.6. D.10. D.10.8.r. R2. D.10.8.r.6. D.10. D.10.8.r. R2. D.10.8.r.6. D.10. D.10.8.r. R2. D.10.8.r.6. D.10. D.10.8.r. R2. D.10.8.r.6. </outboundRelationship2>. D.10. D.10.8.r. R2. D.10.8.r.7. <outboundRelationship2 typeCode="CAUS">. D.10. D.10.8.r. R2. D.10.8.r.7. D.10. D.10.8.r. R2. D.10.8.r.7. D.10. D.10.8.r. R2. D.10.8.r.7. D.10. D.10.8.r. R2. D.10.8.r.7. D.10. D.10.8.r. R2. D.10.8.r.7. D.10. D.10.8.r. R2. D.10. D.10.8.r. R2. Name of Drug as Reported. </kindOfProduct> </instanceOfKind>. <observation classCode="OBS" moodCode="EVN">. D.10.8.r.6a. MedDRA Version for Indication. D.10.8.r.6b. Indication (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="indication"/> <value xsi:type="CE" code="D.10.8.r.6b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.10.8.r.6a"/> </observation>. <observation classCode="OBS" moodCode="EVN">. D.10.8.r.7a. MedDRA Version for Reaction. D.10.8.r.7b. Reactions (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reaction"/> <value xsi:type="CE" code="D.10.8.r.7b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.10.8.r.7a"/> </observation> </outboundRelationship2> </substanceAdministration> </component>. D.10. </organizer>. D.10. </subjectOf2>. D.10. </role> </player1> <subjectOf1 typeCode="SBJ"> <researchStudy classCode="CLNTRL" moodCode="EVN">. C. C.5.3. C.5.3. C.5.3. C. C.5.4. C.5.4. C.5.4. C.5.2. C.5.2. C. C.5.2. C. C.5.1.r. R1. C. C.5.1.r. R1. C. C.5.1.r. R1. C.5.1.r.1. C. C.5.1.r. R1. C.5.1.r.2. C. C.5.1.r. R1. C.5.1.r.2. C. C.5.1.r. R1. C.5.1.r.2. Sponsor Study Number Study Type Where Reaction(s) / Event(s) Were Observed Study Name. 2.1.3.5. <id extension="C.5.3" root="2.16.840.1.113883.3.989.2.1.3.5"/>. 2.1.1.8. <code code="C.5.4" codeSystem="2.16.840.1.113883.3.989.2.1.1.8" codeSystemVersion="1.0"/> <title>C.5.2</title> <authorization typeCode="AUTH"> <studyRegistration classCode="ACT" moodCode="EVN">. C.5.1.r.1. Study Registration Number. 2.1.3.6. <id extension="C.5.1.r.1" root="2.16.840.1.113883.3.989.2.1.3.6"/> <author typeCode="AUT"> <territorialAuthority classCode="TERR"> <governingPlace classCode="COUNTRY" determinerCode="INSTANCE">.

(34) 1.0.3166.1.2. 2. C. C.5.1.r. R1. C.5.1.r.2. C. C.5.1.r. R1. C.5.1.r.2. C. C.5.1.r. R1. C.5.1.r.2. C. C.5.1.r. R1. C.5.1.r.2. C. C.5.1.r. R1. C. C.5.1.r. R1. </authorization>. C. C.5.1.r. R2. <authorization typeCode="AUTH">. C. C.5.1.r. R2. C. C.5.1.r. R2. C.5.1.r.1. C. C.5.1.r. R2. C.5.1.r.2. C. C.5.1.r. R2. C.5.1.r.2. C. C.5.1.r. R2. C.5.1.r.2. C. C.5.1.r. R2. C.5.1.r.2. C. C.5.1.r. R2. C.5.1.r.2. C. C.5.1.r. R2. C.5.1.r.2. C. C.5.1.r. R2. C.5.1.r.2. C. C.5.1.r. R2. C. C.5.1.r. R2. C.5.1.r.2. Study Registration Country. <code code="C.5.1.r.2" codeSystem="1.0.3166.1.2.2"/> </governingPlace> </territorialAuthority> </author> </studyRegistration>. <studyRegistration classCode="ACT" moodCode="EVN"> C.5.1.r.1. 2.1.3.6. StudyRegistration Number. <id extension="C.5.1.r.1" root="2.16.840.1.113883.3.989.2.1.3.6"/> <author typeCode="AUT"> <territorialAuthority classCode="TERR"> <governingPlace classCode="COUNTRY" determinerCode="INSTANCE">. C.5.1.r.2. 1.0.3166.1.2. 2. Study Registration Country. <code code="C.5.1.r.2" codeSystem="1.0.3166.1.2.2"/> </governingPlace> </territorialAuthority> </author> </studyRegistration> </authorization>. C. </researchStudy>. C. </subjectOf1>. D. D.2.2. D. D.2.2. <subjectOf2 typeCode="SBJ">. D. D.2.2. D. D.2.2. D. D.2.2. D. D.2.2. </subjectOf2>. D. D.2.2.1. <subjectOf2 typeCode="SBJ">. D. D.2.2.1. D. D.2.2.1. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.2.2a. Age at Time of Onset of Reaction D.2.2b / Event (number). Age at Time of Onset of Reaction / Event (unit). <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="age"/> <value xsi:type="PQ" value="10" unit="D.2.2b"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Gestation Period When Reaction / Event Was Observed in the Foetus (value). Gestation Period When Reaction / Event Was Observed in the Foetus (unit). <code code="16" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="gestationPeriod"/>. D. D.2.2.1. D. D.2.2.1. D. D.2.2.1. </subjectOf2>. D. D.2.3. <subjectOf2 typeCode="SBJ">. D. D.2.3. D. D.2.3. D. D.2.3. D. D.2.3. D. D.2.3. </subjectOf2>. D. D.3. <subjectOf2 typeCode="SBJ">. D. D.3. D. D.3. D. D.3. D. D.3. D. D.3. </subjectOf2>. D. D.4. <subjectOf2 typeCode="SBJ">. D. D.4. D. D.4. D. D.4. D. D.4. D. D.4. </subjectOf2>. D. D.6. <subjectOf2 typeCode="SBJ">. D. D.6. D. D.6. D.2.2.1a. D.2.2.1b. <value xsi:type="PQ" value="10" unit="D.2.2.1b"/>. </observation>. <observation classCode="OBS" moodCode="EVN">. D.2.3. Patient Age Group (as per reporter). 2.1.1.19. <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="ageGroup"/>. 2.1.1.9. <value xsi:type="CE" code="D.2.3" codeSystem="2.16.840.1.113883.3.989.2.1.1.9" codeSystemVersion="1.0"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.3. <code code="7" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="bodyWeight"/> <value xsi:type="PQ" value="48.2" unit="kg"/>. Body Weight (kg). </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.4. <code code="17" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="height"/> <value xsi:type="PQ" value="152" unit="cm"/>. Height (cm). </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19. <code code="22" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="lastMenstrualPeriodDate"/>.

(35) D. D.6. D. D.6. D. D.6. D.6. <value xsi:type="TS" value="20090101"/>. Last Menstrual Period Date. </observation> </subjectOf2>. D. <subjectOf2 typeCode="SBJ">. D. <organizer classCode="CATEGORY" moodCode="EVN">. D. 2.1.1.20. D. D.7.1.r. R1. D. D.7.1.r. R1. <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="1.0" displayName="relevantMedicalHistoryAndConcurrentConditions"/> <component typeCode="COMP"> <observation classCode="OBS" moodCode="EVN">. D.7.1.r.1a. Medical History MedDRA Version (disease / surgical D.7.1.r.1b for Medical History procedure / etc.) (MedDRA code). D.7.1.r.2, 4. D.7.1.r.2. Start Date. <low value="20090101"/>. R1. D.7.1.r.2, 4. D.7.1.r.4. End Date. <high value="20090101"/>. D.7.1.r. R1. D.7.1.r.2, 4. </effectiveTime>. D.7.1.r. R1. D.7.1.r.5. <outboundRelationship2 typeCode="COMP">. D. D.7.1.r. R1. D.7.1.r.5. D. D.7.1.r. R1. D.7.1.r.5. D. D.7.1.r. R1. D.7.1.r.5. D. D.7.1.r. R1. D.7.1.r.5. D. D.7.1.r. R1. D.7.1.r.5. </outboundRelationship2>. D. D.7.1.r. R1. D.7.1.r.6. <outboundRelationship2 typeCode="EXPL">. D. D.7.1.r. R1. D.7.1.r.6. D. D.7.1.r. R1. D.7.1.r.6. D. D.7.1.r. R1. D.7.1.r.6. D. D.7.1.r. R1. D.7.1.r.6. D. D.7.1.r. R1. D.7.1.r.6. </outboundRelationship2>. D. D.7.1.r. R1. D.7.1.r.3. <inboundRelationship typeCode="REFR">. D. D.7.1.r. R1. D.7.1.r.3. D. D.7.1.r. R1. D.7.1.r.3. D. D.7.1.r. R1. D.7.1.r.3. D. D.7.1.r. R1. D.7.1.r.3. D. D.7.1.r. R1. D.7.1.r.3. D. D.7.1.r. R1. D. D.7.1.r. R1. </component>. D. D.7.1.r. R2. <component typeCode="COMP">. D. D.7.1.r. R2. D. D.7.1.r. R1. D.7.1.r.1. D. D.7.1.r. R1. D.7.1.r.2, 4. D. D.7.1.r. R1. D. D.7.1.r. D D. 2.16.840.1.1 13883.6.163. <code code="D.7.1.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.7.1.r.1a"/> <effectiveTime xsi:type="IVL_TS">. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.7.1.r.5. <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="comment"/> <value xsi:type="ED">D.7.1.r.5</value>. Comments. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.7.1.r.6. <code code="38" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="familyHistory"/> <value xsi:type="BL" value="true"/>. Family History. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.7.1.r.3. <code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="continuing"/> <value xsi:type="BL" value="true"/>. Continuing. </observation> </inboundRelationship> </observation>. <observation classCode="OBS" moodCode="EVN">. D.7.1.r.1a. Medical history MedDRA Version (disease / surgical D.7.1.r.1b for Medical History procedure / etc.) (MedDRA code). D.7.1.r.2, 4. D.7.1.r.2. Start Date. <low value="20090101"/>. R2. D.7.1.r.2, 4. D.7.1.r.4. End Date. <high value="20090101"/>. D.7.1.r. R2. D.7.1.r.2, 4. </effectiveTime>. D.7.1.r. R2. D.7.1.r.5. <outboundRelationship2 typeCode="COMP">. D. D.7.1.r. R2. D.7.1.r.5. D. D.7.1.r. R2. D.7.1.r.5. D. D.7.1.r. R2. D.7.1.r.5. D. D.7.1.r. R2. D.7.1.r.5. D. D.7.1.r. R2. D.7.1.r.5. </outboundRelationship2>. D. D.7.1.r. R2. D.7.1.r.6. <outboundRelationship2 typeCode="EXPL">. D. D.7.1.r. R2. D.7.1.r.6. D. D.7.1.r. R2. D.7.1.r.6. D. D.7.1.r. R2. D.7.1.r.6. D. D.7.1.r. R2. D.7.1.r.6. D. D.7.1.r. R2. D.7.1.r.6. </outboundRelationship2>. D. D.7.1.r. R2. D.7.1.r.3. <inboundRelationship typeCode="REFR">. D. D.7.1.r. R2. D.7.1.r.3. D. D.7.1.r. R2. D.7.1.r.3. D. D.7.1.r. R2. D.7.1.r.1. D. D.7.1.r. R2. D.7.1.r.2, 4. D. D.7.1.r. R2. D. D.7.1.r. D D. 2.16.840.1.1 13883.6.163. <code code="D.7.1.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.7.1.r.1a"/> <effectiveTime xsi:type="IVL_TS">. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.7.1.r.5. <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="comment"/> <value xsi:type="ED">D.7.1.r.5</value>. Comments. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.7.1.r.6. <code code="38" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="familyHistory"/> <value xsi:type="BL" value="true"/>. Family History. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19. <code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="continuing"/>.

(36) D. D.7.1.r. R2. D.7.1.r.3. D. D.7.1.r. R2. D.7.1.r.3. D. D.7.1.r. R2. D.7.1.r.3. D. D.7.1.r. R2. D. D.7.1.r. R2. D.7.1.r.3. <value xsi:type="BL" value="true"/>. Continuing. </observation> </inboundRelationship> </observation> </component>. D. D.7.2. D. D.7.2. D. D.7.2. <component typeCode="COMP"> <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Text for Relevant Medical History and Concurrent Conditions (not including reaction / event). <code code="18" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="historyAndConcurrentConditionText"/>. D. D.7.2. D. D.7.2. D. D.7.2. </component>. D. D.7.3. <component typeCode="COMP">. D. D.7.3. D. D.7.3. D. D.7.3. D. D.7.3. D. D.7.3. D.7.2. <value xsi:type="ED">D.7.2</value>. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 D.7.3. <code code="11" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="concomitantTherapy"/> <value xsi:type="BL" value="true"/>. Concomitant Therapies. </observation> </component>. D. </organizer>. D. </subjectOf2>. D. <subjectOf2 typeCode="SBJ">. D. <organizer classCode="CATEGORY" moodCode="EVN">. D. 2.1.1.20. <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" codeSystemVersion="1.0" displayName="drugHistory"/>. D. D.8.r. R1. <component typeCode="COMP">. D. D.8.r. R1. D. D.8.r. R1. D.8.r.4, 5. D. D.8.r. R1. D.8.r.4, 5. D.8.r.4. Start Date. <low value="20090101"/>. D. D.8.r. R1. D.8.r.4, 5. D.8.r.5. End Date. <high value="20090101"/>. D. D.8.r. R1. D.8.r.4, 5. </effectiveTime>. D. D.8.r. R1. D.8.r.1, 2. <consumable typeCode="CSM">. D. D.8.r. R1. D.8.r.1, 2. D. D.8.r. R1. D.8.r.1, 2. D. D.8.r. R1. D.8.r.1, 2. D.8.r.2a. D. D.8.r. R1. D.8.r.1, 2. D.8.r.1. D. D.8.r. R1. D.8.r.1, 2. </kindOfProduct>. D. D.8.r. R1. D.8.r.1, 2. </instanceOfKind>. D. D.8.r. R1. D.8.r.1, 2. </consumable>. D. D.8.r. R1. D.8.r.6. <outboundRelationship2 typeCode="RSON">. D. D.8.r. R1. D.8.r.6. D. D.8.r. R1. D.8.r.6. D. D.8.r. R1. D.8.r.6. D. D.8.r. R1. D.8.r.6. D. D.8.r. R1. D.8.r.6. </outboundRelationship2>. D. D.8.r. R1. D.8.r.7. <outboundRelationship2 typeCode="CAUS">. D. D.8.r. R1. D.8.r.7. D. D.8.r. R1. D.8.r.7. D. D.8.r. R1. D.8.r.7. D. D.8.r. R1. D.8.r.7. D. D.8.r. R1. D.8.r.7. D. D.8.r. R1. D. D.8.r. R1. </component>. D. D.8.r. R2. <component typeCode="COMP">. D. D.8.r. R2. D. D.8.r. R2. D.8.r.4, 5. D. D.8.r. R2. D.8.r.4, 5. <substanceAdministration classCode="SBADM" moodCode="EVN"> <effectiveTime xsi:type="IVL_TS">. <instanceOfKind classCode="INST"> <kindOfProduct classCode="MMAT" determinerCode="KIND"> MPID Version Date / Number Name of Drug as Reported. D.8.r.2b. Medicinal Product Identifier (MPID). TBD-MPID. <code code="D.8.r.2b" codeSystem="TBD-MPID" codeSystemVersion="D.8.r.2a"/> <name>D.8.r.1</name>. <observation classCode="OBS" moodCode="EVN">. D.8.r.6a. MedDRA Version for Indication. D.8.r.6b. Indication (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="indication"/> <value xsi:type="CE" code="D.8.r.6b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.8.r.6a"/> </observation>. <observation classCode="OBS" moodCode="EVN">. D.8.r.7a. MedDRA Version for Reaction. D.8.r.7b. Reaction (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reaction"/> <value xsi:type="CE" code="D.8.r.7b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.8.r.7a"/> </observation> </outboundRelationship2> </substanceAdministration>. <substanceAdministration classCode="SBADM" moodCode="EVN"> <effectiveTime xsi:type="IVL_TS"> D.8.r.4. Start Date. <low value="20090101"/>.

(37) D. D.8.r. R2. D.8.r.4, 5. D. D.8.r. R2. D.8.r.4, 5. </effectiveTime>. D. D.8.r. R2. D.8.r.1, 3. <consumable typeCode="CSM">. D. D.8.r. R2. D.8.r.1, 3. D. D.8.r. R2. D.8.r.1, 3. D. D.8.r. R2. D.8.r.1, 3. D.8.r.5. <high value="20090101"/>. End Date. <instanceOfKind classCode="INST"> <kindOfProduct classCode="MMAT" determinerCode="KIND"> D.8.r.3a. PhPID Version Date / Number. D.8.r.1. Name of Drug as Reported. D.8.r.3b. Pharmaceutical Product Identifier (PhPID). TBD-PhPID. <code code="D.8.r.3b" codeSystem="TBD-PhPID" codeSystemVersion="D.8.r.3a"/> <name>D.8.r.1</name>. D. D.8.r. R2. D.8.r.1, 3. D. D.8.r. R2. D.8.r.1, 3. D. D.8.r. R2. D.8.r.1, 3. D. D.8.r. R2. D.8.r.1, 3. </consumable>. D. D.8.r. R2. D.8.r.6. <outboundRelationship2 typeCode="RSON">. D. D.8.r. R2. D.8.r.6. D. D.8.r. R2. D.8.r.6. D. D.8.r. R2. D.8.r.6. D. D.8.r. R2. D.8.r.6. D. D.8.r. R2. D.8.r.6. </outboundRelationship2>. D. D.8.r. R2. D.8.r.7. <outboundRelationship2 typeCode="CAUS">. D. D.8.r. R2. D.8.r.7. D. D.8.r. R2. D.8.r.7. D. D.8.r. R2. D.8.r.7. D. D.8.r. R2. D.8.r.7. D. D.8.r. R2. D. D.8.r. R2. D. D.8.r. R2. </kindOfProduct> </instanceOfKind>. <observation classCode="OBS" moodCode="EVN">. D.8.r.6a. MedDRA Version for Indication. D.8.r.6b. Indication (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="indication"/> <value xsi:type="CE" code="D.8.r.6b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.8.r.6a"/> </observation>. <observation classCode="OBS" moodCode="EVN">. D.8.r.7a. MedDRA Version for Reaction. D.8.r.7b. Reaction (MedDRA code). 2.1.1.19 2.16.840.1.1 13883.6.163. <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reaction"/> <value xsi:type="CE" code="D.8.r.7b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.8.r.7a"/> </observation> </outboundRelationship2> </substanceAdministration> </component>. D. </organizer>. D. </subjectOf2>. D. D.9.2.r. R1. D.9.2.r.1, 2. D. D.9.2.r. R1. D.9.2.r.1, 2. <subjectOf2 typeCode="SBJ">. D. D.9.2.r. R1. D.9.2.r.1, 2. D. D.9.2.r. R1. D.9.2.r.1, 2. D.9.2.r.1a. D. D.9.2.r. R1. D.9.2.r.1, 2. D.9.2.r.2. D. D.9.2.r. R1. D.9.2.r.1, 2. D. D.9.2.r. R1. D.9.2.r.1, 2. D. D.9.2.r. R1. D.9.2.r.1, 2. </subjectOf2>. D. D.9.2.r. R2. D.9.2.r.1, 2. <subjectOf2 typeCode="SBJ">. D. D.9.2.r. R2. D.9.2.r.1, 2. D. D.9.2.r. R2. D.9.2.r.1, 2. <observation classCode="OBS" moodCode="EVN"> MedDRA Version Reported Cause(s) D.9.2.r.1b of Death (MedDRA for Reported Cause(s) of Death code) Reported Cause(s) of Death (free. 2.1.1.19. <code code="32" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reportedCauseOfDeath"/>. 2.16.840.1.1 13883.6.163. <value xsi:type="CE" code="D.9.2.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.9.2.r.1a"> <originalText>D.9.2.r.2</originalText> </value> </observation>. <observation classCode="OBS" moodCode="EVN">. D. D.9.2.r. R2. D.9.2.r.1, 2. D.9.2.r.1a. D. D.9.2.r. R2. D.9.2.r.1, 2. D.9.2.r.2. D. D.9.2.r. R2. D.9.2.r.1, 2. D. D.9.2.r. R2. D.9.2.r.1, 2. D. D.9.2.r. R2. D.9.2.r.1, 2. MedDRA Version Reported Cause(s) D.9.2.r.1b of Death (MedDRA for Reported Cause(s) of Death code) Reported Cause(s) of Death (free. 2.1.1.19. <code code="32" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reportedCauseOfDeath"/>. 2.16.840.1.1 13883.6.163. <value xsi:type="CE" code="D.9.2.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.9.2.r.1a"> <originalText>D.9.2.r.2</originalText> </value> </observation> </subjectOf2>. D. <subjectOf2 typeCode="SBJ">. D. <observation classCode="OBS" moodCode="EVN">. D. D.9.3. D. D.9.3. D. D.9.4.r. R1. D.9.4.r.1, 2. D. D.9.4.r. R1. D.9.4.r.1, 2. D. D.9.4.r. R1. D.9.4.r.1, 2. D. D.9.4.r. R1. D.9.4.r.1, 2. 2.1.1.19 D.9.3. WasAutopsyDone?. <code code="5" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="autopsy"/> <value xsi:type="BL" value="true"/> <outboundRelationship2 typeCode="DRIV"> <observation classCode="OBS" moodCode="EVN">. D.9.4.r.1a. MedDRA Version Autopsyfor Autopsydetermined D.9.4.r.1b determined Cause(s) of Death Cause(s) of Death (MedDRA code). 2.1.1.19. <code code="8" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="causeOfDeath"/>. 2.16.840.1.1 13883.6.163. <value xsi:type="CE" code="D.9.4.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.9.4.r.1a">.

(38) Autopsydetermined Cause(s) of Death (free text). D. D.9.4.r. R1. D.9.4.r.1, 2. D. D.9.4.r. R1. D.9.4.r.1, 2. D. D.9.4.r. R1. D.9.4.r.1, 2. D. D.9.4.r. R1. D.9.4.r.1, 2. </outboundRelationship2>. D. D.9.4.r. R2. D.9.4.r.1, 2. <outboundRelationship2 typeCode="DRIV">. D. D.9.4.r. R2. D.9.4.r.1, 2. D. D.9.4.r. R2. D.9.4.r.1, 2. D.9.4.r.2. <originalText>D.9.4.r.2</originalText> </value> </observation>. <observation classCode="OBS" moodCode="EVN">. D. D.9.4.r. R2. D.9.4.r.1, 2. D.9.4.r.1a. D. D.9.4.r. R2. D.9.4.r.1, 2. D.9.4.r.2. D. D.9.4.r. R2. D.9.4.r.1, 2. D. D.9.4.r. R2. D.9.4.r.1, 2. D. D.9.4.r. R2. D.9.4.r.1, 2. MedDRA Version Autopsyfor Autopsydetermined D.9.4.r.1b determined Cause(s) of Death Cause(s) of Death (MedDRA code) Autopsydetermined Cause(s) of Death (free text). 2.1.1.19. <code code="8" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="causeOfDeath"/>. 2.16.840.1.1 13883.6.163. <value xsi:type="CE" code="D.9.4.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="D.9.4.r.1a">. <originalText>D.9.4.r.2</originalText> </value> </observation> </outboundRelationship2>. D. </observation>. D. </subjectOf2>. E. E.i. i1. E. E.i. i1. <subjectOf2 typeCode="SBJ">. E. E.i. i1. E. E.i. i1. E. E.i. i1. E.i.4, 5. E. E.i. i1. E.i.4, 5. E.i.4. E. E.i. i1. E.i.4, 5. E.i.5. E. E.i. i1. E.i.4, 5. E. E.i. i1. E.i.2.1. <observation classCode="OBS" moodCode="EVN"> <id root="154eb889-958b-45f2-a02f-42d4d6f4657f"/>. Event ID 2.1.1.19. E. E.i. i1. E.i.1.1. E. E.i. i1. E. E.i. i1. E.i.9. E. E.i. i1. E.i.9. E. E.i. i1. E.i.9. <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reaction"/> <effectiveTime xsi:type="IVL_TS"> <low value="20090101"/>. Date of Start of Reaction / Event Date of End of Reaction / Event. <high value="20090102"/> </effectiveTime>. E.i.2.1a. E.i.1.1a. MedDRA Version for Reaction / Event Reaction / Event as Reported by the Primary Source in Native. E.i.2.1b. Reaction / Event (MedDRA code). E.i.1.1b. Reaction / Event as Reported by the Primary Source Language. 2.16.840.1.1 13883.6.163. <value xsi:type="CE" code="E.i.2.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="E.i.2.1a">. <originalText language="E.i.1.1b">E.i.1.1a</originalText> </value> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE">. Identification of the Country Where the Reaction / Event Occurred. 1.0.3166.1.2. 2. E. E.i. i1. E.i.9. E. E.i. i1. E.i.9. E. E.i. i1. E.i.9. E. E.i. i1. E.i.9. </location>. E. E.i. i1. E.i.1.2. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.1.2. E. E.i. i1. E.i.1.2. E.i.9. <code code="E.i.9" codeSystem="1.0.3166.1.2.2"/> </locatedPlace> </locatedEntity>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Reaction / Event as Reported by the Primary Source for. <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reactionForTranslation"/> <value xsi:type="ED">E.i.1.2</value>. E. E.i. i1. E.i.1.2. E. E.i. i1. E.i.1.2. E. E.i. i1. E.i.1.2. </outboundRelationship2>. E. E.i. i1. E.i.3.1. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.3.1. E. E.i. i1. E.i.3.1. E. E.i. i1. E.i.3.1. E. E.i. i1. E.i.3.1. E. E.i. i1. E.i.3.1. </outboundRelationship2>. E. E.i. i1. E.i.3.2a. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.3.2a. E.i.1.2. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.1. Term Highlighted by the Reporter. 2.1.1.10. <code code="37" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="termHighlightedByReporter"/> <value xsi:type="CE" code="E.i.3.1" codeSystem="2.16.840.1.113883.3.989.2.1.1.10" codeSystemVersion="1.0"/> </observation>. <observation classCode="OBS" moodCode="EVN">.

(39) E E E. E.i E.i E.i. i1 i1 i1. E.i.3.2a E.i.3.2a E.i.3.2a. 2.1.1.19. E. E.i. i1. E.i.3.2a. </outboundRelationship2>. E. E.i. i1. E.i.3.2b. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.3.2b. E E E. E.i E.i E.i. i1 i1 i1. E.i.3.2b E.i.3.2b E.i.3.2b. E. E.i. i1. E.i.3.2b. </outboundRelationship2>. E. E.i. i1. E.i.3.2c. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.3.2c. E. E.i. i1. E.i.3.2c. E. E.i. i1. E.i.3.2c. E. E.i. i1. E.i.3.2c. E. E.i. i1. E.i.3.2c. </outboundRelationship2>. E. E.i. i1. E.i.3.2d. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.3.2d. E. E.i. i1. E.i.3.2d. E. E.i. i1. E.i.3.2d. E. E.i. i1. E.i.3.2d. E. E.i. i1. E.i.3.2d. </outboundRelationship2>. E. E.i. i1. E.i.3.2e. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.3.2e. E. E.i. i1. E.i.3.2e. E.i.3.2a. Results in Death. <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="resultsInDeath"/> <value xsi:type="BL" value="true"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.2b. Life Threatening. <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="isLifeThreatening"/> <value xsi:type="BL" nullFlavor="NI"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.2c. Caused / Prolonged Hospitalisation. <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="requiresInpatientHospitalization"/> <value xsi:type="BL" value="true"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.2d. <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="resultsInPersistentOrSignificantDisability"/> <value xsi:type="BL" nullFlavor="NI"/>. Disabling / Incapacitating. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Congenital Anomaly / Birth Defect. <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="congenitalAnomalyBirthDefect"/>. E. E.i. i1. E.i.3.2e. E. E.i. i1. E.i.3.2e. E. E.i. i1. E.i.3.2e. </outboundRelationship2>. E. E.i. i1. E.i.3.2f. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.3.2f. E. E.i. i1. E.i.3.2f. E.i.3.2e. <value xsi:type="BL" nullFlavor="NI"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Other Medically Important Condition. <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="otherMedicallyImportantCondition"/>. E. E.i. i1. E.i.3.2f. E. E.i. i1. E.i.3.2f. E. E.i. i1. E.i.3.2f. </outboundRelationship2>. E. E.i. i1. E.i.7. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.7. E. E.i. i1. E.i.7. E.i.3.2f. <value xsi:type="BL" value="true"/> </observation>. <observation classCode="OBS" moodCode="EVN"> Outcome of Reaction / Event at the Time of Last Observation. 2.1.1.19. <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="outcome"/>. 2.1.1.11. <value xsi:type="CE" code="E.i.7" codeSystem="2.16.840.1.113883.3.989.2.1.1.11" codeSystemVersion="1.0"/>. E. E.i. i1. E.i.7. E. E.i. i1. E.i.7. E. E.i. i1. E.i.7. </outboundRelationship2>. E. E.i. i1. E.i.8. <outboundRelationship2 typeCode="PERT">. E. E.i. i1. E.i.8. E. E.i. i1. E.i.8. E.i.7. </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Medical Confirmation by Healthcare Professional. <code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="medicalConfirmationByHealthProfessional"/>. E. E.i. i1. E.i.8. E. E.i. i1. E.i.8. E. E.i. i1. E.i.8. E. E.i. i1. E. E.i. i1. </subjectOf2>. E. E.i. i2. <subjectOf2 typeCode="SBJ">. E. E.i. i2. E. E.i. i2. E. E.i. i2. E.i.8. <value xsi:type="BL" value="true"/> </observation> </outboundRelationship2> </observation>. <observation classCode="OBS" moodCode="EVN"> Event ID. <id root="2baa28d6-c9e8-4e6c-93e9-5b860b314220"/> 2.1.1.19. <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reaction"/>.

(40) E. E.i. i2. E.i.4, 6. E. E.i. i2. E.i.4, 6. E. E.i. i2. E.i.4, 6. E. E.i. i2. E.i.4, 6. E. E.i. i2. E.i.2.1. E. E.i. i2. E.i.1.1. E. E.i. i2. E. E.i. i2. E.i.9. E. E.i. i2. E.i.9. E. E.i. i2. E.i.9. <effectiveTime xsi:type="IVL_TS"> E.i.4 E.i.6a. Date of Start of Reaction / Event Duration of Reaction / Event (number). <low value="20090101"/> E.i.6b. Duration of Reaction / Event (unit). <width value="24" unit="E.i.6b"/> </effectiveTime>. E.i.2.1a. E.i.1.1a. MedDRA Version for Reaction / Event Reaction / Event as Reported by the Primary Source in Native. E.i.2.1b. Reaction / Event (MedDRA code). E.i.1.1b. Reaction / Event as Reported by the Primary Source Language. 2.16.840.1.1 13883.6.163. <value xsi:type="CE" code="E.i.2.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="E.i.2.1a">. <originalText language="E.i.1.1b">E.i.1.1a</originalText> </value> <location typeCode="LOC"> <locatedEntity classCode="LOCE"> <locatedPlace classCode="COUNTRY" determinerCode="INSTANCE">. Identification of the Country Where the Reaction / Event Occurred. 1.0.3166.1.2. 2. E. E.i. i2. E.i.9. E. E.i. i2. E.i.9. E. E.i. i2. E.i.9. E. E.i. i2. E.i.9. </location>. E. E.i. i2. E.i.1.2. <outboundRelationship2 typeCode="PERT">. E. E.i. i2. E.i.1.2. E. E.i. i2. E.i.1.2. E.i.9. <code code="E.i.9" codeSystem="1.0.3166.1.2.2"/> </locatedPlace> </locatedEntity>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 Reaction / Event as Reported by the Primary Source for. <code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="reactionForTranslation"/>. E. E.i. i2. E.i.1.2. E. E.i. i2. E.i.1.2. E. E.i. i2. E.i.1.2. </outboundRelationship2>. E. E.i. i2. E.i.3.1. <outboundRelationship2 typeCode="PERT">. E. E.i. i2. E.i.3.1. E. E.i. i2. E.i.3.1. E. E.i. i2. E.i.3.1. E. E.i. i2. E.i.3.1. E. E.i. i2. E.i.3.1. </outboundRelationship2>. E. E.i. i2. E.i.3.2a. <outboundRelationship2 typeCode="PERT">. E. E.i. i2. E.i.3.2a. E E E. E.i E.i E.i. i2 i2 i2. E.i.3.2a E.i.3.2a E.i.3.2a. E. E.i. i2. E.i.3.2a. </outboundRelationship2>. E. E.i. i2. E.i.3.2b. <outboundRelationship2 typeCode="PERT">. E. E.i. i2. E.i.3.2b. E E E. E.i E.i E.i. i2 i2 i2. E.i.3.2b E.i.3.2b E.i.3.2b. E. E.i. i2. E.i.3.2b. </outboundRelationship2>. E. E.i. i2. E.i.3.2c. <outboundRelationship2 typeCode="PERT">. E. E.i. i2. E.i.3.2c. E. E.i. i2. E.i.3.2c. E. E.i. i2. E.i.3.2c. E. E.i. i2. E.i.3.2c. E. E.i. i2. E.i.3.2c. </outboundRelationship2>. E. E.i. i2. E.i.3.2d. <outboundRelationship2 typeCode="PERT">. E. E.i. i2. E.i.3.2d. E. E.i. i2. E.i.3.2d. E. E.i. i2. E.i.3.2d. E. E.i. i2. E.i.3.2d. E. E.i. i2. E.i.3.2d. E.i.1.2. <value xsi:type="ED">E.i.1.2</value> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.1. Term Highlighted by the Reporter. 2.1.1.10. <code code="37" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="termHighlightedByReporter"/> <value xsi:type="CE" code="E.i.3.1" codeSystem="2.16.840.1.113883.3.989.2.1.1.10" codeSystemVersion="1.0"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.2a. Results in Death. <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="resultsInDeath"/> <value xsi:type="BL" value="true"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.2b. Life Threatening. <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="isLifeThreatening"/> <value xsi:type="BL" nullFlavor="NI"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.2c. Caused / Prolonged Hospitalisation. <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="requiresInpatientHospitalization"/> <value xsi:type="BL" value="true"/> </observation>. <observation classCode="OBS" moodCode="EVN"> 2.1.1.19 E.i.3.2d. Disabling / Incapacitating. <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" codeSystemVersion="1.1" displayName="resultsInPersistentOrSignificantDisability"/> <value xsi:type="BL" nullFlavor="NI"/> </observation> </outboundRelationship2>.

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