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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121878013 | 12187801 | 3 | F | 20151118 | 20160629 | 20160317 | 20160711 | EXP | US-ACTELION-A-US2015-127341 | ACTELION | 60.00 | YR | A | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121878013 | 12187801 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | EP105P0101,IP060P0101;OP019P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 121878013 | 12187801 | 2 | C | TYVASO | TREPROSTINIL | 1 | U | 0 | |||||||||||
| 121878013 | 12187801 | 3 | C | ADCIRCA | TADALAFIL | 1 | U | 0 | |||||||||||
| 121878013 | 12187801 | 4 | C | TREPROSTINIL DIOLAMIN | TREPROSTINIL DIOLAMINE | 1 | U | 0 | |||||||||||
| 121878013 | 12187801 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 121878013 | 12187801 | 6 | C | WARFARIN | WARFARIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121878013 | 12187801 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121878013 | 12187801 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121878013 | 12187801 | Abdominal pain upper | |
| 121878013 | 12187801 | Asthenia | |
| 121878013 | 12187801 | Cough | |
| 121878013 | 12187801 | Diarrhoea | |
| 121878013 | 12187801 | Ear infection | |
| 121878013 | 12187801 | Epistaxis | |
| 121878013 | 12187801 | International normalised ratio increased | |
| 121878013 | 12187801 | Liver function test increased | |
| 121878013 | 12187801 | Oxygen consumption increased | |
| 121878013 | 12187801 | Physical disability | |
| 121878013 | 12187801 | Pneumonia | |
| 121878013 | 12187801 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 121878013 | 12187801 | 1 | 20100528 | 0 |