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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125028792 | 12502879 | 2 | F | 20150426 | 20160711 | 20160628 | 20160720 | EXP | JP-ACTELION-A-CH2016-138243 | ACTELION | 66.00 | YR | E | M | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125028792 | 12502879 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | 93.75 | MG | 21290 | 125 | MG | TABLET | BID | ||||
| 125028792 | 12502879 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 31.25 MG, QD | 93.75 | MG | 21290 | 31.25 | MG | TABLET | QD | ||||
| 125028792 | 12502879 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, QD | 93.75 | MG | 21290 | 62.5 | MG | TABLET | QD | ||||
| 125028792 | 12502879 | 4 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, QD | 93.75 | MG | 21290 | 125 | MG | TABLET | QD | ||||
| 125028792 | 12502879 | 5 | C | OXYGEN. | OXYGEN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125028792 | 12502879 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125028792 | 12502879 | DE |
| 125028792 | 12502879 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125028792 | 12502879 | Cardiac failure | |
| 125028792 | 12502879 | Condition aggravated |
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 |
|---|---|---|---|---|---|---|
| 125028792 | 12502879 | 1 | 20150610 | 20150626 | 0 | |
| 125028792 | 12502879 | 2 | 20130424 | 20130427 | 0 | |
| 125028792 | 12502879 | 3 | 20130428 | 20130529 | 0 | |
| 125028792 | 12502879 | 4 | 20130530 | 20150609 | 0 |