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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123662692 | 12366269 | 2 | F | 20160607 | 20160705 | 20160513 | 20160715 | EXP | US-ACTELION-A-NJ2016-131033 | ACTELION | 52.00 | YR | A | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123662692 | 12366269 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | U | OP019P0101,OP021P0101, OP023P0101 | 21290 | 125 | MG | TABLET | BID | ||||
| 123662692 | 12366269 | 2 | SS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 70 NG/KG, PER MIN | MM083M0101 | 22260 | INJECTION | /min | |||||||
| 123662692 | 12366269 | 3 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123662692 | 12366269 | 1 | Pulmonary arterial hypertension |
| 123662692 | 12366269 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123662692 | 12366269 | DE |
| 123662692 | 12366269 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123662692 | 12366269 | Cardiac disorder | |
| 123662692 | 12366269 | Death | |
| 123662692 | 12366269 | Lung disorder | |
| 123662692 | 12366269 | Pulmonary hypertension | |
| 123662692 | 12366269 | Transplant evaluation |
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 |
|---|---|---|---|---|---|---|
| 123662692 | 12366269 | 1 | 20090727 | 0 | ||
| 123662692 | 12366269 | 2 | 20110414 | 20160607 | 0 |