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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126917194 | 12691719 | 4 | F | 20160919 | 20160826 | 20160926 | EXP | US-ACTELION-A-NJ2016-141419 | ACTELION | 56.00 | YR | A | F | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126917194 | 12691719 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 126917194 | 12691719 | 2 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6-9 TIMES DAILY | MA02DL05 | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 126917194 | 12691719 | 3 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 126917194 | 12691719 | 4 | C | WARFARIN | WARFARIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126917194 | 12691719 | 1 | Pulmonary arterial hypertension |
| 126917194 | 12691719 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126917194 | 12691719 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126917194 | 12691719 | Blood count abnormal | |
| 126917194 | 12691719 | Diarrhoea | |
| 126917194 | 12691719 | Faeces discoloured | |
| 126917194 | 12691719 | Fatigue | |
| 126917194 | 12691719 | Hepatic enzyme increased |
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 |
|---|---|---|---|---|---|---|
| 126917194 | 12691719 | 1 | 20111228 | 0 | ||
| 126917194 | 12691719 | 2 | 20090617 | 0 |