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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124059422 | 12405942 | 2 | F | 20160622 | 20160526 | 20160707 | EXP | US-CIPLA LTD.-2016US05951 | CIPLA | 0.00 | Y | 0.00000 | 20160707 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124059422 | 12405942 | 1 | PS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Transplacental | 1 TOTAL DAILY DOSE | 90561 | TABLET | |||||||||
| 124059422 | 12405942 | 2 | SS | Tenofovir/Emtricitabine | EMTRICITABINETENOFOVIR | 1 | Transplacental | 1 TOTAL DAILY DOSE | 0 | TABLET | |||||||||
| 124059422 | 12405942 | 3 | SS | TIVICAY | DOLUTEGRAVIR SODIUM | 1 | Transplacental | 1 TOTAL DAILY DOSE | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124059422 | 12405942 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124059422 | 12405942 | Foetal exposure during pregnancy | |
| 124059422 | 12405942 | Mass | |
| 124059422 | 12405942 | Pericardial effusion |
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 |
|---|---|---|---|---|---|---|
| 124059422 | 12405942 | 1 | 20160405 | 0 | ||
| 124059422 | 12405942 | 2 | 20160505 | 0 | ||
| 124059422 | 12405942 | 3 | 20160505 | 0 |