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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126359051 | 12635905 | 1 | I | 20151216 | 20160802 | 20160809 | 20160809 | EXP | DE-ACTELION-A-CH2016-140255 | ACTELION | 78.00 | YR | E | M | Y | 0.00000 | 20160808 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126359051 | 12635905 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | Y | 21290 | 62.5 | MG | TABLET | BID | |||||
| 126359051 | 12635905 | 2 | SS | CANDESARTAN | CANDESARTAN | 1 | Oral | 16 MG, UNK | Y | 0 | 16 | MG | |||||||
| 126359051 | 12635905 | 3 | SS | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 20 MG, QD | Y | 0 | 20 | MG | QD | ||||||
| 126359051 | 12635905 | 4 | C | SPIRONOLACTON | SPIRONOLACTONE | 1 | Oral | UNK | U | 0 | |||||||||
| 126359051 | 12635905 | 5 | C | MARCUMAR | PHENPROCOUMON | 1 | Oral | UNK | U | 0 | |||||||||
| 126359051 | 12635905 | 6 | C | RIOCIGUAT | RIOCIGUAT | 1 | Oral | 2.5 MG, UNK | U | 0 | 2.5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126359051 | 12635905 | 1 | Pulmonary arterial hypertension |
| 126359051 | 12635905 | 2 | Product used for unknown indication |
| 126359051 | 12635905 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126359051 | 12635905 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126359051 | 12635905 | Alanine aminotransferase increased | |
| 126359051 | 12635905 | Aspartate aminotransferase increased | |
| 126359051 | 12635905 | Blood alkaline phosphatase increased | |
| 126359051 | 12635905 | Blood bilirubin increased | |
| 126359051 | 12635905 | Gamma-glutamyltransferase increased | |
| 126359051 | 12635905 | Hepatic failure | |
| 126359051 | 12635905 | Transaminases increased |
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 |
|---|---|---|---|---|---|---|
| 126359051 | 12635905 | 1 | 201502 | 0 | ||
| 126359051 | 12635905 | 2 | 201502 | 0 | ||
| 126359051 | 12635905 | 3 | 201501 | 0 |