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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115013346 | 11501334 | 6 | F | 20160204 | 20160706 | 20150914 | 20160718 | EXP | US-ACTELION-A-NJ2015-123794 | ACTELION | 7.00 | YR | C | M | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115013346 | 11501334 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | Y | U | NP011A0101,HP015P0101, DP061P0112 | 21290 | 62.5 | MG | TABLET | BID | |||
| 115013346 | 11501334 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 62.5 MG, BID | Y | U | NP013P0402 | 21290 | 62.5 | MG | TABLET | BID | |||
| 115013346 | 11501334 | 3 | C | REMODULIN | TREPROSTINIL | 1 | Y | U | 0 | ||||||||||
| 115013346 | 11501334 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115013346 | 11501334 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115013346 | 11501334 | OT |
| 115013346 | 11501334 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115013346 | 11501334 | Asthenia | |
| 115013346 | 11501334 | Atrial septal defect repair | |
| 115013346 | 11501334 | Cardiac disorder | |
| 115013346 | 11501334 | Chest pain | |
| 115013346 | 11501334 | Condition aggravated | |
| 115013346 | 11501334 | Diarrhoea | |
| 115013346 | 11501334 | Dyspnoea | |
| 115013346 | 11501334 | Lung disorder | |
| 115013346 | 11501334 | Lung transplant | |
| 115013346 | 11501334 | Nausea | |
| 115013346 | 11501334 | Pulmonary arterial hypertension |
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 |
|---|---|---|---|---|---|---|
| 115013346 | 11501334 | 1 | 2015 | 0 | ||
| 115013346 | 11501334 | 2 | 20160129 | 0 |