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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115946426 | 11594642 | 6 | F | 20160622 | 20151005 | 20160706 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2015-124392 | ACTELION | 78.00 | YR | E | M | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115946426 | 11594642 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP056P0101, EP105P0101,OP021P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 115946426 | 11594642 | 2 | C | TYVASO | TREPROSTINIL | 1 | U | 0 | |||||||||||
| 115946426 | 11594642 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 115946426 | 11594642 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115946426 | 11594642 | 1 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115946426 | 11594642 | Abdominal discomfort | |
| 115946426 | 11594642 | Asthenia | |
| 115946426 | 11594642 | Dizziness | |
| 115946426 | 11594642 | Dyspnoea | |
| 115946426 | 11594642 | Lung infection | |
| 115946426 | 11594642 | Nasal congestion | |
| 115946426 | 11594642 | Non-cardiac chest pain | |
| 115946426 | 11594642 | Pneumonia | |
| 115946426 | 11594642 | Productive cough | |
| 115946426 | 11594642 | Scab | |
| 115946426 | 11594642 | Sinusitis | |
| 115946426 | 11594642 | Thirst | |
| 115946426 | 11594642 | Viral infection | |
| 115946426 | 11594642 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 115946426 | 11594642 | 1 | 20110131 | 0 |