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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125394621 | 12539462 | 1 | I | 201505 | 20160628 | 20160708 | 20160708 | EXP | FR-ACTELION-A-CH2016-138849 | ACTELION | 46.00 | YR | A | F | Y | 59.00000 | KG | 20160708 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125394621 | 12539462 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | Y | U | 21290 | 62.5 | MG | TABLET | BID | ||||
| 125394621 | 12539462 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | Y | U | 21290 | TABLET | |||||||
| 125394621 | 12539462 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | Y | U | 21290 | 125 | MG | TABLET | BID | ||||
| 125394621 | 12539462 | 4 | C | TRAMADOL. | TRAMADOL | 1 | U | 0 | |||||||||||
| 125394621 | 12539462 | 5 | C | METHOTREXATE. | METHOTREXATE | 1 | 10 MG, UNK | U | 0 | 10 | MG | ||||||||
| 125394621 | 12539462 | 6 | C | SPECIAFOLDINE | FOLIC ACID | 1 | U | 0 | |||||||||||
| 125394621 | 12539462 | 7 | C | CORTANCYL | PREDNISONE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125394621 | 12539462 | 1 | Scleroderma associated digital ulcer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125394621 | 12539462 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125394621 | 12539462 | Chest pain | |
| 125394621 | 12539462 | Palpitations | |
| 125394621 | 12539462 | Pericarditis | |
| 125394621 | 12539462 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 125394621 | 12539462 | 1 | 20141127 | 201505 | 0 | |
| 125394621 | 12539462 | 2 | 2015 | 0 | ||
| 125394621 | 12539462 | 3 | 20141224 | 201505 | 0 |