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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124061503 | 12406150 | 3 | F | 20160427 | 20160621 | 20160526 | 20160705 | EXP | US-SUN PHARMACEUTICAL INDUSTRIES LTD-2016US-117003 | RANBAXY | 0.00 | Y | 0.00000 | 20160705 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124061503 | 12406150 | 1 | PS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Transplacental | 1 DF, DAILY | Y | 77327 | 1 | DF | |||||||
| 124061503 | 12406150 | 2 | SS | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | 1 DF, DAILY | 0 | 1 | DF | ||||||||
| 124061503 | 12406150 | 3 | SS | TIVICAY | DOLUTEGRAVIR SODIUM | 1 | Transplacental | 1 DF, DAILY | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124061503 | 12406150 | 1 | HIV infection |
| 124061503 | 12406150 | 2 | HIV infection |
| 124061503 | 12406150 | 3 | HIV infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124061503 | 12406150 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124061503 | 12406150 | Foetal exposure during pregnancy | |
| 124061503 | 12406150 | Haemangioma | |
| 124061503 | 12406150 | Haemangioma congenital | |
| 124061503 | 12406150 | Maternal drugs affecting foetus | |
| 124061503 | 12406150 | Pericardial effusion | |
| 124061503 | 12406150 | Postmature baby |
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 |
|---|---|---|---|---|---|---|
| 124061503 | 12406150 | 1 | 20160405 | 0 | ||
| 124061503 | 12406150 | 2 | 20160505 | 0 | ||
| 124061503 | 12406150 | 3 | 20160505 | 0 |