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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123984445 | 12398444 | 5 | F | 20160711 | 20160714 | 20160524 | 20160726 | PER | US-ACTELION-A-US2016-135764 | ACTELION | 61.00 | YR | A | F | Y | 81.63000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123984445 | 12398444 | 1 | PS | UPTRAVI | SELEXIPAG | 1 | Oral | 200 MCG, BID | Y | 031004701, | 207947 | 200 | UG | TABLET | BID | ||||
| 123984445 | 12398444 | 2 | SS | UPTRAVI | SELEXIPAG | 1 | Oral | 200 MCG, QD | Y | 031004901 | 207947 | 200 | UG | TABLET | QD | ||||
| 123984445 | 12398444 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | Y | OP023P0101 | 21290 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123984445 | 12398444 | 1 | Pulmonary hypertension |
| 123984445 | 12398444 | 3 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123984445 | 12398444 | DE |
| 123984445 | 12398444 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123984445 | 12398444 | Abdominal distension | |
| 123984445 | 12398444 | Abdominal pain | |
| 123984445 | 12398444 | Ammonia increased | |
| 123984445 | 12398444 | Asthenia | |
| 123984445 | 12398444 | Condition aggravated | |
| 123984445 | 12398444 | Death | |
| 123984445 | 12398444 | Decreased appetite | |
| 123984445 | 12398444 | Diarrhoea | |
| 123984445 | 12398444 | Dizziness | |
| 123984445 | 12398444 | Dyspnoea | |
| 123984445 | 12398444 | Hepatic cirrhosis | |
| 123984445 | 12398444 | Liver function test increased | |
| 123984445 | 12398444 | Malaise | |
| 123984445 | 12398444 | Nausea | |
| 123984445 | 12398444 | Right ventricular failure | |
| 123984445 | 12398444 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 123984445 | 12398444 | 1 | 20160422 | 0 |