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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123812362 | 12381236 | 2 | F | 201512 | 20160811 | 20160518 | 20160816 | EXP | CN-ACTELION-A-CH2016-136008 | ACTELION | 32.00 | YR | A | F | Y | 0.00000 | 20160816 | CN | CN | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123812362 | 12381236 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 21290 | 125 | MG | TABLET | BID | ||||||
| 123812362 | 12381236 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | 21290 | 62.5 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123812362 | 12381236 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123812362 | 12381236 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123812362 | 12381236 | Death |
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 |
|---|---|---|---|---|---|---|
| 123812362 | 12381236 | 1 | 201512 | 0 | ||
| 123812362 | 12381236 | 2 | 20141230 | 0 |