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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125171052 | 12517105 | 2 | F | 20160718 | 20160630 | 20160728 | PER | US-ACTELION-A-US2016-138389 | ACTELION | 72.00 | YR | E | M | Y | 0.00000 | 20160729 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125171052 | 12517105 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 125 MG, BID | OP023P0101, OP026P0101 | 21290 | 125 | MG | TABLET | BID | |||||
125171052 | 12517105 | 2 | SS | UPTRAVI | SELEXIPAG | 1 | Oral | 800 MCG, BID | U | U | 0310244 | 207947 | 800 | UG | TABLET | BID | |||
125171052 | 12517105 | 3 | SS | UPTRAVI | SELEXIPAG | 1 | Oral | 1400 MCG, BID | U | U | 0310244 | 207947 | 1400 | UG | TABLET | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125171052 | 12517105 | 1 | Pulmonary arterial hypertension |
125171052 | 12517105 | 2 | Pulmonary arterial hypertension |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125171052 | 12517105 | Headache | |
125171052 | 12517105 | Nausea | |
125171052 | 12517105 | Pollakiuria | |
125171052 | 12517105 | Urine flow decreased |
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 |
---|---|---|---|---|---|---|
125171052 | 12517105 | 1 | 20140916 | 0 | ||
125171052 | 12517105 | 2 | 20160524 | 0 | ||
125171052 | 12517105 | 3 | 20160524 | 0 |