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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123391484 | 12339148 | 4 | F | 20150713 | 20160901 | 20160505 | 20160913 | EXP | US-ACTELION-A-NJ2015-121387 | ACTELION | 72.00 | YR | E | F | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123391484 | 12339148 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM012N0501,UM016A0201,UM019A0101 | 204410 | 10 | MG | TABLET | QD | |||||
| 123391484 | 12339148 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123391484 | 12339148 | 1 | Pulmonary arterial hypertension |
| 123391484 | 12339148 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123391484 | 12339148 | HO |
| 123391484 | 12339148 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123391484 | 12339148 | Asthenia | |
| 123391484 | 12339148 | Death | |
| 123391484 | 12339148 | Dyspnoea | |
| 123391484 | 12339148 | Fall | |
| 123391484 | 12339148 | Fatigue | |
| 123391484 | 12339148 | Fluid retention | |
| 123391484 | 12339148 | Infection | |
| 123391484 | 12339148 | Myopathy | |
| 123391484 | 12339148 | Oedema | |
| 123391484 | 12339148 | Swelling | |
| 123391484 | 12339148 | Walking disability |
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 |
|---|---|---|---|---|---|---|
| 123391484 | 12339148 | 1 | 20150223 | 0 |