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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120855693 | 12085569 | 3 | F | 20150723 | 20160707 | 20160217 | 20160711 | EXP | US-VIIV HEALTHCARE LIMITED-US2016GSK021373 | VIIV | 0.00 | YR | M | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120855693 | 12085569 | 1 | PS | Dolutegravir | DOLUTEGRAVIR | 1 | Transplacental | 50 MG PER DAY | 204790 | TABLET | |||||||||
| 120855693 | 12085569 | 2 | SS | STRIBILD | COBICISTATELVITEGRAVIREMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | 1 TAB/CAPS DAILY | 0 | ||||||||||
| 120855693 | 12085569 | 3 | SS | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Transplacental | 1 TAB/CAPS DAILY | 0 | ||||||||||
| 120855693 | 12085569 | 4 | SS | COCAINE | COCAINE | 1 | Transplacental | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120855693 | 12085569 | 1 | HIV infection |
| 120855693 | 12085569 | 2 | HIV infection |
| 120855693 | 12085569 | 3 | HIV infection |
| 120855693 | 12085569 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120855693 | 12085569 | DE |
| 120855693 | 12085569 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120855693 | 12085569 | Ascites | |
| 120855693 | 12085569 | Foetal exposure during pregnancy | |
| 120855693 | 12085569 | Foetal growth restriction | |
| 120855693 | 12085569 | Hypoperfusion | |
| 120855693 | 12085569 | Intraventricular haemorrhage neonatal | |
| 120855693 | 12085569 | Jaundice cholestatic | |
| 120855693 | 12085569 | Low birth weight baby | |
| 120855693 | 12085569 | Metabolic acidosis | |
| 120855693 | 12085569 | Neonatal respiratory distress syndrome | |
| 120855693 | 12085569 | Pleural effusion | |
| 120855693 | 12085569 | Premature 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 |
|---|---|---|---|---|---|---|
| 120855693 | 12085569 | 1 | 20150731 | 0 | ||
| 120855693 | 12085569 | 2 | 20150731 | 0 | ||
| 120855693 | 12085569 | 3 | 20150731 | 0 |