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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122480633 | 12248063 | 3 | F | 20160301 | 20160902 | 20160408 | 20160909 | EXP | JP-ACTELION-A-CH2016-133049 | ACTELION | 30.00 | YR | A | F | Y | 0.00000 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122480633 | 12248063 | 1 | PS | OPSUMIT | MACITENTAN | 1 | Oral | 10 MG, OD | 280 | MG | Y | 204410 | 10 | MG | TABLET | QD | |||
| 122480633 | 12248063 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | U | U | 21290 | TABLET | |||||||
| 122480633 | 12248063 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | U | U | 21290 | TABLET | |||||||
| 122480633 | 12248063 | 4 | C | TADALAFIL | TADALAFIL | 1 | U | 0 | |||||||||||
| 122480633 | 12248063 | 5 | C | TREPROSTINIL | TREPROSTINIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122480633 | 12248063 | 1 | Pulmonary arterial hypertension |
| 122480633 | 12248063 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122480633 | 12248063 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122480633 | 12248063 | Oedema peripheral | |
| 122480633 | 12248063 | Platelet count decreased | |
| 122480633 | 12248063 | Platelet transfusion | |
| 122480633 | 12248063 | Systemic lupus erythematosus | |
| 122480633 | 12248063 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 122480633 | 12248063 | 1 | 20160216 | 20160329 | 0 | |
| 122480633 | 12248063 | 2 | 20160330 | 0 | ||
| 122480633 | 12248063 | 3 | 20160215 | 0 |