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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123644416 | 12364441 | 6 | F | 201602 | 20160805 | 20160512 | 20160817 | EXP | US-ACTELION-A-NJ2016-135868 | ACTELION | 66.00 | YR | E | F | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123644416 | 12364441 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 61 NG/KG, PER MIN | MM076M0101,MM087M0101, MM089M0101 | 22260 | INJECTION | /min | |||||||
| 123644416 | 12364441 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | U | U | 21290 | TABLET | ||||||||
| 123644416 | 12364441 | 3 | C | WARFARIN | WARFARIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123644416 | 12364441 | 1 | Pulmonary arterial hypertension |
| 123644416 | 12364441 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123644416 | 12364441 | HO |
| 123644416 | 12364441 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123644416 | 12364441 | Breast cellulitis | |
| 123644416 | 12364441 | Epistaxis | |
| 123644416 | 12364441 | Fatigue | |
| 123644416 | 12364441 | Hip fracture | |
| 123644416 | 12364441 | Skin disorder |
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 |
|---|---|---|---|---|---|---|
| 123644416 | 12364441 | 1 | 20110609 | 0 |