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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1169037411 | 11690374 | 11 | F | 201601 | 20160720 | 20151102 | 20160801 | EXP | US-ACTELION-A-NJ2015-126320 | ACTELION | 35.00 | YR | A | F | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1169037411 | 11690374 | 1 | PS | VELETRI | EPOPROSTENOL | 1 | Intravenous (not otherwise specified) | 50 NG/KG, PER MIN | MM060M0101,MM073M0101,MM074M0101 | 22260 | INJECTION | /min | |||||||
| 1169037411 | 11690374 | 2 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | Y | U | 0 | |||||||||
| 1169037411 | 11690374 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 1500226A | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1169037411 | 11690374 | 1 | Pulmonary arterial hypertension |
| 1169037411 | 11690374 | 2 | Product used for unknown indication |
| 1169037411 | 11690374 | 3 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1169037411 | 11690374 | HO |
| 1169037411 | 11690374 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1169037411 | 11690374 | Abdominal pain | |
| 1169037411 | 11690374 | Anaesthetic complication cardiac | |
| 1169037411 | 11690374 | Cholecystectomy | |
| 1169037411 | 11690374 | Cholecystitis | |
| 1169037411 | 11690374 | Cholelithiasis | |
| 1169037411 | 11690374 | Drain placement | |
| 1169037411 | 11690374 | Heart rate decreased | |
| 1169037411 | 11690374 | Hypersensitivity | |
| 1169037411 | 11690374 | Pain | |
| 1169037411 | 11690374 | Pain in extremity | |
| 1169037411 | 11690374 | Peripheral swelling | |
| 1169037411 | 11690374 | Post procedural infection | |
| 1169037411 | 11690374 | Post procedural oedema |
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 |
|---|---|---|---|---|---|---|
| 1169037411 | 11690374 | 1 | 20140415 | 0 | ||
| 1169037411 | 11690374 | 3 | 20141029 | 0 |