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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114007976 | 11400797 | 6 | F | 20160629 | 20150820 | 20160708 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2014-106031 | ACTELION | 82.00 | YR | E | F | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114007976 | 11400797 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 0P010A0102,IP050P0101,IP055P0101V | 21290 | 125 | MG | TABLET | BID | |||||
| 114007976 | 11400797 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | OP023P0101 | 21290 | TABLET | ||||||||
| 114007976 | 11400797 | 3 | SS | RIOCIGUAT | RIOCIGUAT | 1 | Unknown | 1 UNK, UNK | U | U | 0 | QD | |||||||
| 114007976 | 11400797 | 4 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114007976 | 11400797 | 1 | Pulmonary arterial hypertension |
| 114007976 | 11400797 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114007976 | 11400797 | Cough | |
| 114007976 | 11400797 | Diarrhoea | |
| 114007976 | 11400797 | Dizziness | |
| 114007976 | 11400797 | Dyspepsia | |
| 114007976 | 11400797 | Dyspnoea | |
| 114007976 | 11400797 | Fatigue | |
| 114007976 | 11400797 | Feeling abnormal | |
| 114007976 | 11400797 | Headache | |
| 114007976 | 11400797 | Nasopharyngitis | |
| 114007976 | 11400797 | Oedema | |
| 114007976 | 11400797 | Oedema peripheral | |
| 114007976 | 11400797 | Sciatica | |
| 114007976 | 11400797 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 114007976 | 11400797 | 1 | 20100624 | 0 |