SUSPECT ADVERSE REACTION REPORT

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1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 62 DA MO YR (Year) Male Kopfschmerzen jeden 2. Tag beidseits ( ): Headache ] schwere, abnorme Träume täglich ( ): Abnormal dreams ] ( ): Anxiety ] ( ): Tiredness ] ( ): Sleeplessness ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Kopfschmerzen jeden 2. Tag beidseits; täglich schwere, abnorme Träume; Wegen Ängsten konnte der Patient nicht einschlafen. Tagsüber bestand eine Müdigkeit. Die Beschwerden traten etwa ab dem 2. Tag der Einnahme (nach Umstellung von Truvada auf Descovy) auf und hörten nach Rückumstellung nach ca. 1-2 Tagen komplett auf. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (include generic name) Descovy 200 mg/25 mg II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 1 Df dosage form every Day" [ 25 Df dosage Oral form { 1 Df dosage form, 1 in 1 Day } ] 17. INDICATION(S) FOR USE HIV infection 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 25- to 28-FEB Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) Iisentress from DEC-2008 Iisentress from DEC-2008 (cont.) DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? þ YES NO NA (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 ( ): HIV infection ] Continuing: Unknown [ MedDRA 20.0 ( ): Myocardial infarction ] from FEB-2014 Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 21-JUN-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Kopfschmerzen jeden 2. Tag beidseits [MedDRA 20.0 PT ( ): Headache ] ( ): Headache ] schwere, abnorme Träume täglich [MedDRA 20.0 PT ( ): Abnormal dreams ] ( ): Abnormal dreams ] [MedDRA 20.0 PT ( ): Anxiety ] ( ): Anxiety ] [MedDRA 20.0 PT ( ): Fatigue ] ( ): Tiredness ] [MedDRA 20.0 PT ( ): Insomnia ] ( ): Sleeplessness ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Descovy 200 mg/25 mg 25-JAN FEB Day A: daily dose: 1 Df dosage form every Day B: 25Df dosage form C: 1Df dosage form D: 1 E: 1Day Oral HIV infection Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application

3 Report Page: 3 of 6 Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? NA * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name emtricitabine tenofovir alafenamide fumarate Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Headache ] [ MedDRA 20.0 ( ): Abnormal dreams ] [ MedDRA 20.0 ( ): Anxiety ] [ MedDRA 20.0 ( ): Tiredness ] [ MedDRA 20.0 ( ): Sleeplessness ] 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Iisentress DEC A: B: C: 2Df dosage form D: E: 1Day Oral HIV infection Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure

4 Report Page: 4 of 6 Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Dose not changed Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name raltegravir 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) ASS 100 FEB A: daily dose: 100 Mg milligram(s) every Day B: C: 100Mg milligram(s) D: 1 E: 1Day Oral Stent placement Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name acetylsalicylic acid

5 Report Page: 5 of Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 ( ): HIV infection ] Unknown C3 [ MedDRA 20.0 ( ): Myocardial infarction ] FEB Patient past drug therapy Name of drug as reported truvada Indication MedDRA code [ MedDRA 20.0 ( ): HIV infection ] Reactions MedDRA code Start End [ MedDRA 20.0 (0): unbekannt ] ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Yes Was the case medically confirmed, if not initially from health professional? Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 70 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country

6 Report Page: 6 of 6 Fax Telephone address PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 76 Height (cm) 172 Last menstrual periode Text for relevant medical history and concurrent conditions

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