Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126821511 | 12682151 | 1 | I | 20150831 | 20160824 | 20160824 | EXP | US-GILEAD-2015-0170386 | GILEAD | 0.00 | YR | M | Y | 3.34000 | KG | 20160824 | MD | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126821511 | 12682151 | 1 | PS | EMTRICITABINE/RILPIVIRINE/TENOFOVIR DF | EMTRICITABINERILPIVIRINETENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | 1 DF, QD | 166 | DF | KNHF | 202123 | 1 | DF | TABLET | QD | |||
| 126821511 | 12682151 | 2 | SS | DARUNAVIR | DARUNAVIR | 1 | Transplacental | UNK | KNHF | 0 | TABLET | ||||||||
| 126821511 | 12682151 | 3 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | 8 MG, QD | 1328 | MG | 0 | 8 | MG | TABLET | QD | ||||
| 126821511 | 12682151 | 4 | SS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Transplacental | 300 MG, BID | 0 | 300 | MG | TABLET | BID | ||||||
| 126821511 | 12682151 | 5 | SS | DIFLUCAN | FLUCONAZOLE | 1 | Transplacental | 0 | 150 | MG | TABLET | QD | |||||||
| 126821511 | 12682151 | 6 | SS | MACROBID | NITROFURANTOINNITROFURANTOIN MONOHYDRATE | 1 | Transplacental | UNK | 0 | ||||||||||
| 126821511 | 12682151 | 7 | SS | FLUVIRIN /01389801/ | INFLUENZA VIRUS VACCINE | 1 | Transplacental | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126821511 | 12682151 | 1 | HIV infection |
| 126821511 | 12682151 | 2 | Infection prophylaxis |
| 126821511 | 12682151 | 3 | Product used for unknown indication |
| 126821511 | 12682151 | 4 | Product used for unknown indication |
| 126821511 | 12682151 | 5 | Product used for unknown indication |
| 126821511 | 12682151 | 6 | Product used for unknown indication |
| 126821511 | 12682151 | 7 | Immunisation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126821511 | 12682151 | HO |
| 126821511 | 12682151 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126821511 | 12682151 | Foetal exposure during pregnancy | |
| 126821511 | 12682151 | Jaundice | |
| 126821511 | 12682151 | Meconium in amniotic fluid | |
| 126821511 | 12682151 | Vomiting | |
| 126821511 | 12682151 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126821511 | 12682151 | 1 | 20150226 | 20150811 | 0 | |
| 126821511 | 12682151 | 2 | 20150427 | 20150811 | 0 | |
| 126821511 | 12682151 | 3 | 20150226 | 20150811 | 0 | |
| 126821511 | 12682151 | 4 | 20150226 | 20150811 | 0 | |
| 126821511 | 12682151 | 5 | 20150226 | 20150319 | 0 | |
| 126821511 | 12682151 | 6 | 20150220 | 20150226 | 0 | |
| 126821511 | 12682151 | 7 | 20150319 | 20150319 | 0 |