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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119713805 | 11971380 | 5 | F | 20160915 | 20160128 | 20160928 | PER | US-ACTELION PHARMACEUTICALS US, INC.-A-US2016-130511 | ACTELION | 70.00 | YR | E | F | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119713805 | 11971380 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP019P0101,OP021P0101, OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 119713805 | 11971380 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | 21290 | 62.5 | MG | TABLET | BID | ||||||
| 119713805 | 11971380 | 3 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 119713805 | 11971380 | 4 | C | DILTIAZEM. | DILTIAZEM | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119713805 | 11971380 | 1 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119713805 | 11971380 | Asthenia | |
| 119713805 | 11971380 | Blood iron abnormal | |
| 119713805 | 11971380 | Chest discomfort | |
| 119713805 | 11971380 | Condition aggravated | |
| 119713805 | 11971380 | Dizziness | |
| 119713805 | 11971380 | Dyspnoea | |
| 119713805 | 11971380 | Fatigue | |
| 119713805 | 11971380 | Headache | |
| 119713805 | 11971380 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 119713805 | 11971380 | 1 | 20160119 | 0 | ||
| 119713805 | 11971380 | 2 | 2010 | 201509 | 0 |