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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127167782 | 12716778 | 2 | F | 20160814 | 20160919 | 20160906 | 20160922 | EXP | US-GILEAD-2016-0229235 | GILEAD | 53.00 | YR | A | F | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127167782 | 12716778 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 5 MG, QD | 1413180A | 22081 | 5 | MG | TABLET | QD | |||||
| 127167782 | 12716778 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | 22081 | TABLET | |||||||||||
| 127167782 | 12716778 | 3 | SS | VENTAVIS | ILOPROST | 1 | Unknown | UNK, QID | N | 0 | QID | ||||||||
| 127167782 | 12716778 | 4 | SS | TRACLEER | BOSENTAN | 1 | Unknown | 125 MG, BID | N | 0 | 125 | MG | BID | ||||||
| 127167782 | 12716778 | 5 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 127167782 | 12716778 | 6 | C | CARVEDILOL. | CARVEDILOL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127167782 | 12716778 | 1 | Pulmonary arterial hypertension |
| 127167782 | 12716778 | 2 | Fallot's tetralogy |
| 127167782 | 12716778 | 3 | Product used for unknown indication |
| 127167782 | 12716778 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127167782 | 12716778 | CA |
| 127167782 | 12716778 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127167782 | 12716778 | Drug ineffective | |
| 127167782 | 12716778 | Dyspnoea | |
| 127167782 | 12716778 | Eye allergy | |
| 127167782 | 12716778 | Fatigue | |
| 127167782 | 12716778 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 127167782 | 12716778 | 1 | 20160814 | 0 |