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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123214653 | 12321465 | 3 | F | 20150711 | 20160630 | 20160502 | 20160711 | EXP | NL-ACTELION-A-CH2015-120969 | ACTELION | 62.00 | YR | A | M | Y | 0.00000 | 20160711 | OT | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123214653 | 12321465 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | UNK , UNK | 22260 | INJECTION | |||||||||
| 123214653 | 12321465 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 131250 | MG | 21290 | 125 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123214653 | 12321465 | 1 | Pulmonary arterial hypertension |
| 123214653 | 12321465 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123214653 | 12321465 | HO |
| 123214653 | 12321465 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123214653 | 12321465 | Blood iron decreased | |
| 123214653 | 12321465 | Death | |
| 123214653 | 12321465 | Device infusion issue | |
| 123214653 | 12321465 | Fluid retention | |
| 123214653 | 12321465 | Incorrect drug administration rate | |
| 123214653 | 12321465 | Malaise | |
| 123214653 | 12321465 | Medical observation normal | |
| 123214653 | 12321465 | Skin discolouration | |
| 123214653 | 12321465 | Therapy cessation |
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 |
|---|---|---|---|---|---|---|
| 123214653 | 12321465 | 1 | 20140425 | 20160630 | 0 | |
| 123214653 | 12321465 | 2 | 20150122 | 20160630 | 0 |