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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114234578 | 11423457 | 8 | F | 20160630 | 20150827 | 20160711 | EXP | US-ACTELION-A-NJ2015-122986 | ACTELION | 78.00 | YR | E | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114234578 | 11423457 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP055P0101, EP105P0101,EP041P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 114234578 | 11423457 | 2 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 114234578 | 11423457 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 114234578 | 11423457 | 4 | C | NIFEDIPINE. | NIFEDIPINE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114234578 | 11423457 | 1 | Pulmonary arterial hypertension |
| 114234578 | 11423457 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114234578 | 11423457 | HO |
| 114234578 | 11423457 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114234578 | 11423457 | Cardiac disorder | |
| 114234578 | 11423457 | Finger amputation | |
| 114234578 | 11423457 | Heart valve replacement | |
| 114234578 | 11423457 | Internal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 114234578 | 11423457 | 1 | 20040916 | 0 |