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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121221673 | 12122167 | 3 | F | 20160202 | 20160706 | 20160226 | 20160718 | EXP | US-ACTELION-A-US2016-131798 | ACTELION | 77.00 | YR | E | F | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121221673 | 12122167 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, UNK | U | U | 21290 | 125 | MG | TABLET | QD | ||||
| 121221673 | 12122167 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | U | U | 21290 | 125 | MG | TABLET | BID | ||||
| 121221673 | 12122167 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 250 MG, BID | U | U | 21290 | 250 | MG | TABLET | |||||
| 121221673 | 12122167 | 4 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, UNK | U | U | 21290 | 125 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121221673 | 12122167 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121221673 | 12122167 | OT |
| 121221673 | 12122167 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121221673 | 12122167 | Dialysis | |
| 121221673 | 12122167 | Dyspnoea | |
| 121221673 | 12122167 | Hypotension | |
| 121221673 | 12122167 | Oedema | |
| 121221673 | 12122167 | Overdose |
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 |
|---|---|---|---|---|---|---|
| 121221673 | 12122167 | 1 | 20130328 | 0 | ||
| 121221673 | 12122167 | 4 | 20160708 | 0 |