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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124032286 | 12403228 | 6 | F | 20160825 | 20160525 | 20160912 | PER | US-ACTELION-A-US2016-136592 | ACTELION | 92.00 | YR | E | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124032286 | 12403228 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 187.5 MG, BID | OP023P0101,OP026P0101 | 21290 | 187.5 | MG | TABLET | BID | |||||
| 124032286 | 12403228 | 2 | SS | RIOCIGUAT | RIOCIGUAT | 1 | Oral | 2.5 MG, TID | 0 | 2.5 | MG | TID | |||||||
| 124032286 | 12403228 | 3 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124032286 | 12403228 | 1 | Pulmonary arterial hypertension |
| 124032286 | 12403228 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124032286 | 12403228 | Abdominal pain | |
| 124032286 | 12403228 | Asthenia | |
| 124032286 | 12403228 | Blood glucose decreased | |
| 124032286 | 12403228 | Confusional state | |
| 124032286 | 12403228 | Contusion | |
| 124032286 | 12403228 | Diarrhoea | |
| 124032286 | 12403228 | Dizziness | |
| 124032286 | 12403228 | Fall | |
| 124032286 | 12403228 | Fatigue | |
| 124032286 | 12403228 | Feeling abnormal | |
| 124032286 | 12403228 | Hypotension | |
| 124032286 | 12403228 | Lethargy | |
| 124032286 | 12403228 | Malaise | |
| 124032286 | 12403228 | Nausea | |
| 124032286 | 12403228 | Proctalgia | |
| 124032286 | 12403228 | Somnolence | |
| 124032286 | 12403228 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 124032286 | 12403228 | 1 | 20130128 | 0 |