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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1026196114 | 10261961 | 14 | F | 20131217 | 20160713 | 20140626 | 20160719 | EXP | US-ACTELION-A-US2013-92821 | ACTELION | 64.00 | YR | A | F | Y | 0.00000 | 20160719 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1026196114 | 10261961 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP042P0101,IP041P0101,IP044P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 1026196114 | 10261961 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | EP099P0101,IP049P0101,OP010A0102 | 21290 | TABLET | ||||||||
| 1026196114 | 10261961 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | UNK | IP054P0101,OP021P0101 | 21290 | TABLET | ||||||||
| 1026196114 | 10261961 | 4 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, 3-9XDAILY | MA00M4H,MA00M4H,MA00TID,MA00ZXNMA02 | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 1026196114 | 10261961 | 5 | SS | VENTAVIS | ILOPROST | 1 | Respiratory (inhalation) | 5 MCG, UNK | MA00TID,MA00ZXN,MA025XK,MA0299X | 21779 | 5 | UG | INHALATION VAPOUR, SOLUTION | ||||||
| 1026196114 | 10261961 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 1026196114 | 10261961 | 7 | C | LETAIRIS | AMBRISENTAN | 1 | U | 0 | |||||||||||
| 1026196114 | 10261961 | 8 | C | ASPIRIN. | ASPIRIN | 1 | U | 0 | |||||||||||
| 1026196114 | 10261961 | 9 | C | ELIQUIS | APIXABAN | 1 | U | 0 | |||||||||||
| 1026196114 | 10261961 | 10 | C | ADCIRCA | TADALAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1026196114 | 10261961 | 1 | Pulmonary arterial hypertension |
| 1026196114 | 10261961 | 4 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1026196114 | 10261961 | HO |
| 1026196114 | 10261961 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1026196114 | 10261961 | Asthenia | |
| 1026196114 | 10261961 | Bedridden | |
| 1026196114 | 10261961 | Cardiac failure chronic | |
| 1026196114 | 10261961 | Cardiac failure congestive | |
| 1026196114 | 10261961 | Clostridium difficile infection | |
| 1026196114 | 10261961 | Dyspnoea | |
| 1026196114 | 10261961 | Fluid overload | |
| 1026196114 | 10261961 | Fluid retention | |
| 1026196114 | 10261961 | Hypotonia | |
| 1026196114 | 10261961 | Oedema | |
| 1026196114 | 10261961 | Pain in extremity | |
| 1026196114 | 10261961 | Pulmonary hypertension | |
| 1026196114 | 10261961 | Thrombosis | |
| 1026196114 | 10261961 | Urinary tract infection | |
| 1026196114 | 10261961 | Wound |
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 |
|---|---|---|---|---|---|---|
| 1026196114 | 10261961 | 1 | 20110117 | 0 | ||
| 1026196114 | 10261961 | 4 | 20091215 | 0 |