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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125003142 | 12500314 | 2 | F | 20160415 | 20160630 | 20160627 | 20160711 | EXP | JP-ACTELION-A-CH2016-135179 | ACTELION | 66.00 | YR | E | F | Y | 64.00000 | KG | 20160711 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125003142 | 12500314 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 250 MG, QD | 123250 | MG | Y | 21290 | 250 | MG | TABLET | QD | |||
| 125003142 | 12500314 | 2 | C | TADALAFIL | TADALAFIL | 1 | U | 0 | |||||||||||
| 125003142 | 12500314 | 3 | C | CARVEDILOL. | CARVEDILOL | 1 | U | 0 | |||||||||||
| 125003142 | 12500314 | 4 | C | WARFARIN | WARFARIN | 1 | U | 0 | |||||||||||
| 125003142 | 12500314 | 5 | C | RANITIDINE. | RANITIDINE | 1 | U | 0 | |||||||||||
| 125003142 | 12500314 | 6 | C | TOCOPHEROL | TOCOPHEROL | 1 | U | 0 | |||||||||||
| 125003142 | 12500314 | 7 | C | PITAVASTATIN | PITAVASTATIN | 1 | U | 0 | |||||||||||
| 125003142 | 12500314 | 8 | C | OXYGEN. | OXYGEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125003142 | 12500314 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125003142 | 12500314 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125003142 | 12500314 | Alanine aminotransferase increased | |
| 125003142 | 12500314 | Aspartate aminotransferase increased | |
| 125003142 | 12500314 | Autoimmune hepatitis | |
| 125003142 | 12500314 | Chromaturia | |
| 125003142 | 12500314 | Concomitant disease aggravated | |
| 125003142 | 12500314 | Feeling hot | |
| 125003142 | 12500314 | Gamma-glutamyltransferase increased | |
| 125003142 | 12500314 | Haemorrhage | |
| 125003142 | 12500314 | Hepatic function abnormal | |
| 125003142 | 12500314 | International normalised ratio increased | |
| 125003142 | 12500314 | Malaise | |
| 125003142 | 12500314 | Nasopharyngitis | |
| 125003142 | 12500314 | Right ventricular failure | |
| 125003142 | 12500314 | Weight 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 |
|---|---|---|---|---|---|---|
| 125003142 | 12500314 | 1 | 20141209 | 20160509 | 0 |