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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1190727310 | 11907273 | 10 | F | 20160719 | 20160111 | 20160729 | EXP | US-ACTELION-A-NJ2016-129574 | ACTELION | 64.00 | YR | A | F | Y | 0.00000 | 20160729 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1190727310 | 11907273 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 30 NG/KG, PER MIN | MM074M0101,MM075M0101,MM081M0101 | 22260 | INJECTION | /min | |||||||
| 1190727310 | 11907273 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | IP060P0101, OP019P0101,OP021P0101 | 21290 | 125 | MG | TABLET | BID | |||||
| 1190727310 | 11907273 | 3 | C | ADCIRCA | TADALAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1190727310 | 11907273 | 1 | Pulmonary arterial hypertension |
| 1190727310 | 11907273 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1190727310 | 11907273 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1190727310 | 11907273 | Abdominal distension | |
| 1190727310 | 11907273 | Constipation | |
| 1190727310 | 11907273 | Dyspnoea | |
| 1190727310 | 11907273 | Fall | |
| 1190727310 | 11907273 | Fluid overload | |
| 1190727310 | 11907273 | Fluid retention | |
| 1190727310 | 11907273 | Gait disturbance | |
| 1190727310 | 11907273 | General physical health deterioration | |
| 1190727310 | 11907273 | Pain | |
| 1190727310 | 11907273 | Pulmonary arterial hypertension | |
| 1190727310 | 11907273 | Pulmonary embolism | |
| 1190727310 | 11907273 | Swelling | |
| 1190727310 | 11907273 | Transfusion |
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 |
|---|---|---|---|---|---|---|
| 1190727310 | 11907273 | 1 | 20130724 | 0 | ||
| 1190727310 | 11907273 | 2 | 20111019 | 0 |