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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457462 | 12645746 | 2 | F | 201607 | 20160817 | 20160811 | 20160830 | PER | US-ACTELION-A-US2016-140383 | ACTELION | 56.00 | YR | A | F | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457462 | 12645746 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | UNK | Y | 22260 | INJECTION | ||||||||
| 126457462 | 12645746 | 2 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Oral | 5 MG, QD | Y | SZFH | 0 | 5 | MG | QD | |||||
| 126457462 | 12645746 | 3 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | Y | 1509507A | 0 | 10 | MG | QD | |||||
| 126457462 | 12645746 | 4 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 126457462 | 12645746 | 5 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 126457462 | 12645746 | 6 | C | UPTRAVI | SELEXIPAG | 1 | U | 207947 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126457462 | 12645746 | 1 | Pulmonary arterial hypertension |
| 126457462 | 12645746 | 2 | Pulmonary arterial hypertension |
| 126457462 | 12645746 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126457462 | 12645746 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126457462 | 12645746 | Flushing | |
| 126457462 | 12645746 | Oxygen consumption increased | |
| 126457462 | 12645746 | Pulmonary arterial hypertension | |
| 126457462 | 12645746 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 126457462 | 12645746 | 1 | 201607 | 201607 | 0 | |
| 126457462 | 12645746 | 2 | 20160621 | 0 |