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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115800982 | 11580098 | 2 | F | 201112 | 20160627 | 20150930 | 20160706 | EXP | JP-GILEAD-2013-0073602 | GILEAD | 31.00 | YR | A | F | Y | 53.00000 | KG | 20160706 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115800982 | 11580098 | 1 | PS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 2.5 MG, QD | Y | 22081 | 2.5 | MG | TABLET | QD | |||||
| 115800982 | 11580098 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, QD | Y | 22081 | 5 | MG | TABLET | QD | |||||
| 115800982 | 11580098 | 3 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 2.5 MG, QD | Y | 22081 | 2.5 | MG | TABLET | QD | |||||
| 115800982 | 11580098 | 4 | SS | ARTIST | CARVEDILOL | 1 | Oral | UNK | 0 | ||||||||||
| 115800982 | 11580098 | 5 | C | TRACLEER | BOSENTAN | 1 | Oral | U | U | 0 | |||||||||
| 115800982 | 11580098 | 6 | C | WARFARIN | WARFARIN | 1 | Oral | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115800982 | 11580098 | 1 | Pulmonary arterial hypertension |
| 115800982 | 11580098 | 4 | Product used for unknown indication |
| 115800982 | 11580098 | 5 | Pulmonary arterial hypertension |
| 115800982 | 11580098 | 6 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115800982 | 11580098 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115800982 | 11580098 | Dizziness postural | |
| 115800982 | 11580098 | Maternal exposure during pregnancy | |
| 115800982 | 11580098 | Oedema | |
| 115800982 | 11580098 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 115800982 | 11580098 | 1 | 20111212 | 20111215 | 0 | |
| 115800982 | 11580098 | 2 | 20111216 | 20120120 | 0 | |
| 115800982 | 11580098 | 3 | 20120121 | 20150516 | 0 | |
| 115800982 | 11580098 | 4 | 20150515 | 0 | ||
| 115800982 | 11580098 | 5 | 20111219 | 0 | ||
| 115800982 | 11580098 | 6 | 20150515 | 0 |