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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127818111 | 12781811 | 1 | I | 20151029 | 20160909 | 20160926 | 20160926 | EXP | US-GILEAD-2016-0233357 | GILEAD | 0.00 | YR | N | M | Y | 2.68000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127818111 | 12781811 | 1 | PS | EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINETENOFOVIR DISOPROXIL | 1 | Transplacental | 1 DF, QD | D | 21752 | 1 | DF | TABLET | QD | |||||
| 127818111 | 12781811 | 2 | SS | PREZISTA | DARUNAVIR ETHANOLATE | 1 | Transplacental | 1200 MG, QD | 150000 | MG | D | 0 | 1200 | MG | QD | ||||
| 127818111 | 12781811 | 3 | SS | NORVIR | RITONAVIR | 1 | Transplacental | 200 MG, QD | 25000 | MG | D | 0 | 200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127818111 | 12781811 | 1 | HIV infection |
| 127818111 | 12781811 | 2 | HIV infection |
| 127818111 | 12781811 | 3 | HIV infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127818111 | 12781811 | CA |
| 127818111 | 12781811 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127818111 | 12781811 | Foetal exposure during pregnancy | |
| 127818111 | 12781811 | Renal aplasia | |
| 127818111 | 12781811 | Umbilical cord abnormality |
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 |
|---|---|---|---|---|---|---|
| 127818111 | 12781811 | 1 | 20160525 | 0 | ||
| 127818111 | 12781811 | 2 | 20160121 | 20160525 | 0 | |
| 127818111 | 12781811 | 3 | 20160121 | 20160525 | 0 |