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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127763521 | 12776352 | 1 | I | 20160915 | 20160923 | 20160923 | EXP | FR-009507513-1609FRA009019 | MERCK | 0.00 | M | Y | 0.00000 | 20160923 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127763521 | 12776352 | 1 | PS | ISENTRESS | RALTEGRAVIR POTASSIUM | 1 | Oral | 400 MG, BID | Y | 22145 | 400 | MG | TABLET | BID | |||||
| 127763521 | 12776352 | 2 | SS | TRUVADA | EMTRICITABINETENOFOVIR DISOPROXIL FUMARATE | 1 | Oral | 1 DF, QD | Y | 0 | 1 | DF | FILM-COATED TABLET | QD | |||||
| 127763521 | 12776352 | 3 | SS | KARDEGIC | ASPIRIN LYSINE | 1 | Oral | 160 MG, QD | Y | 0 | 160 | MG | POWDER FOR ORAL SOLUTION | QD | |||||
| 127763521 | 12776352 | 4 | C | WELLVONE | ATOVAQUONE | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127763521 | 12776352 | 1 | HIV infection |
| 127763521 | 12776352 | 2 | HIV infection |
| 127763521 | 12776352 | 3 | Ischaemic stroke |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127763521 | 12776352 | OT |
| 127763521 | 12776352 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127763521 | 12776352 | Alanine aminotransferase increased | |
| 127763521 | 12776352 | Aspartate aminotransferase increased | |
| 127763521 | 12776352 | Blood alkaline phosphatase increased | |
| 127763521 | 12776352 | Blood bilirubin increased | |
| 127763521 | 12776352 | Cholestasis | |
| 127763521 | 12776352 | Gamma-glutamyltransferase increased | |
| 127763521 | 12776352 | Hepatocellular injury |
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 |
|---|---|---|---|---|---|---|
| 127763521 | 12776352 | 1 | 20160810 | 20160829 | 0 | |
| 127763521 | 12776352 | 2 | 20160810 | 20160829 | 0 | |
| 127763521 | 12776352 | 3 | 20160811 | 20160829 | 0 | |
| 127763521 | 12776352 | 4 | 20160725 | 20160829 | 0 |