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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127485981 | 12748598 | 1 | I | 201206 | 20120613 | 20160915 | 20160915 | EXP | US-ACTELION-A-NJ2012-67464 | ACTELION | 79.00 | YR | E | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127485981 | 12748598 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | UNK | IP016P0101/IP019P0101/IP024P0101 | 21290 | TABLET | ||||||||
| 127485981 | 12748598 | 2 | C | ASPIRIN. | ASPIRIN | 1 | 0 | ||||||||||||
| 127485981 | 12748598 | 3 | C | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127485981 | 12748598 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127485981 | 12748598 | OT |
| 127485981 | 12748598 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127485981 | 12748598 | Atrial fibrillation | |
| 127485981 | 12748598 | Cardiac failure congestive | |
| 127485981 | 12748598 | Cardiac pacemaker insertion | |
| 127485981 | 12748598 | Cardioversion | |
| 127485981 | 12748598 | Cough | |
| 127485981 | 12748598 | Dysphagia | |
| 127485981 | 12748598 | Dyspnoea | |
| 127485981 | 12748598 | Fatigue | |
| 127485981 | 12748598 | Pneumonia aspiration | |
| 127485981 | 12748598 | Respiratory tract infection | |
| 127485981 | 12748598 | Sinus node dysfunction | |
| 127485981 | 12748598 | Weight fluctuation |
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 |
|---|---|---|---|---|---|---|
| 127485981 | 12748598 | 1 | 20120423 | 0 |