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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119726283 | 11972628 | 3 | F | 20160810 | 20160128 | 20160823 | EXP | US-ACTELION-A-US2016-130480 | ACTELION | 4.00 | YR | C | M | Y | 0.00000 | 20160823 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119726283 | 11972628 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | UNK, BID | HP015P0101 | 21290 | TABLET | BID | |||||||
| 119726283 | 11972628 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 25.6 MG, BID | NP014P0201 | 21290 | 25.6 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119726283 | 11972628 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119726283 | 11972628 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119726283 | 11972628 | Alopecia | |
| 119726283 | 11972628 | Blood potassium decreased | |
| 119726283 | 11972628 | Drug administration error | |
| 119726283 | 11972628 | Heart disease congenital | |
| 119726283 | 11972628 | Hypokalaemia | |
| 119726283 | 11972628 | Pneumonia | |
| 119726283 | 11972628 | Respiratory syncytial virus infection | |
| 119726283 | 11972628 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |