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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98209535 | 9820953 | 5 | F | 20160907 | 20140116 | 20160919 | EXP | US-ACTELION-A-US2012-76865 | ACTELION | 78.00 | YR | E | F | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 98209535 | 9820953 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | DP032P0101/IP042P0101, IP044P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 98209535 | 9820953 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | 21290 | 62.5 | MG | TABLET | BID | ||||||
| 98209535 | 9820953 | 3 | C | LASIX | FUROSEMIDE | 1 | U | 0 | |||||||||||
| 98209535 | 9820953 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 98209535 | 9820953 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 98209535 | 9820953 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 98209535 | 9820953 | Asthenia | |
| 98209535 | 9820953 | Confusional state | |
| 98209535 | 9820953 | Dizziness | |
| 98209535 | 9820953 | Dyspnoea | |
| 98209535 | 9820953 | Fluid retention | |
| 98209535 | 9820953 | Head discomfort | |
| 98209535 | 9820953 | Insomnia | |
| 98209535 | 9820953 | Malaise | |
| 98209535 | 9820953 | Oedema | |
| 98209535 | 9820953 | Oxygen consumption | |
| 98209535 | 9820953 | Productive cough | |
| 98209535 | 9820953 | Renal failure |
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 |
|---|---|---|---|---|---|---|
| 98209535 | 9820953 | 1 | 20121219 | 0 | ||
| 98209535 | 9820953 | 2 | 20130211 | 201303 | 0 |