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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120635554 | 12063555 | 4 | F | 20160128 | 20160817 | 20160210 | 20160829 | EXP | US-ACTELION-A-US2016-130915 | ACTELION | 10.00 | MON | I | F | Y | 0.00000 | 20160829 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120635554 | 12063555 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, 1.4 ML, BID | 21290 | 62.5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120635554 | 12063555 | 1 | Congenital pulmonary artery anomaly |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120635554 | 12063555 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120635554 | 12063555 | Diarrhoea | |
| 120635554 | 12063555 | Diarrhoea haemorrhagic | |
| 120635554 | 12063555 | Pyrexia | |
| 120635554 | 12063555 | Retching | |
| 120635554 | 12063555 | Surgery | |
| 120635554 | 12063555 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 120635554 | 12063555 | 1 | 20151203 | 0 |