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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117425573 | 11742557 | 3 | F | 20160816 | 20151116 | 20160823 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2015-118048 | ACTELION | 73.00 | YR | E | F | Y | 0.00000 | 20160823 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117425573 | 11742557 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, UNK | NP010A0101, DP061P0112, NP014P0201 | 21290 | 62.5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117425573 | 11742557 | 1 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117425573 | 11742557 | Anaemia | |
| 117425573 | 11742557 | Arthritis | |
| 117425573 | 11742557 | Asthenia | |
| 117425573 | 11742557 | Diarrhoea | |
| 117425573 | 11742557 | Drug tolerance | |
| 117425573 | 11742557 | Dyspnoea | |
| 117425573 | 11742557 | Gastrooesophageal reflux disease | |
| 117425573 | 11742557 | Hypokinesia | |
| 117425573 | 11742557 | Sleep disorder |
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 |
|---|---|---|---|---|---|---|
| 117425573 | 11742557 | 1 | 20120130 | 0 |