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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542722 | 12554272 | 2 | F | 20160722 | 20160722 | 20160713 | 20160727 | EXP | US-ACTELION-A-NJ2015-125391 | ACTELION | 68.00 | YR | E | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542722 | 12554272 | 1 | PS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 6-9X/DAY | MA026ST,MA0284U,MA029A9,MA0299X | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 125542722 | 12554272 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | EP105P0101,IP060P0101,OP019P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 125542722 | 12554272 | 3 | SS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, QD | UM019A0101 | 204410 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125542722 | 12554272 | 1 | Pulmonary arterial hypertension |
| 125542722 | 12554272 | 2 | Pulmonary arterial hypertension |
| 125542722 | 12554272 | 3 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125542722 | 12554272 | DE |
| 125542722 | 12554272 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125542722 | 12554272 | Aspiration pleural cavity | |
| 125542722 | 12554272 | Chest pain | |
| 125542722 | 12554272 | Death | |
| 125542722 | 12554272 | Diarrhoea | |
| 125542722 | 12554272 | Dyspnoea | |
| 125542722 | 12554272 | Fluid retention | |
| 125542722 | 12554272 | Pleural effusion | |
| 125542722 | 12554272 | Pulmonary oedema |
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 |
|---|---|---|---|---|---|---|
| 125542722 | 12554272 | 1 | 20120409 | 20160722 | 0 | |
| 125542722 | 12554272 | 2 | 20110826 | 0 | ||
| 125542722 | 12554272 | 3 | 20160714 | 0 |