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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126642722 | 12664272 | 2 | F | 20160816 | 20160818 | 20160829 | EXP | US-ACTELION-A-US2016-140620 | ACTELION | 12.00 | WK | I | M | Y | 0.00000 | 20160829 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126642722 | 12664272 | 1 | PS | TRACLEER | BOSENTAN | 1 | Oral | 6 MG, BID | Y | 21290 | 6 | MG | TABLET | BID | |||||
126642722 | 12664272 | 2 | SS | TRACLEER | BOSENTAN | 1 | Oral | 2.1 MG, BID | Y | 21290 | 2.1 | MG | TABLET | BID | |||||
126642722 | 12664272 | 3 | SS | TRACLEER | BOSENTAN | 1 | Oral | 3 MG, BID | Y | 21290 | 3 | MG | TABLET | BID | |||||
126642722 | 12664272 | 4 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
126642722 | 12664272 | 5 | C | TADALAFIL | TADALAFIL | 1 | Oral | 3 MG, QD | U | 0 | 3 | MG | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126642722 | 12664272 | 1 | Pulmonary arterial hypertension |
126642722 | 12664272 | 4 | Pulmonary arterial hypertension |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126642722 | 12664272 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126642722 | 12664272 | Fluid retention | |
126642722 | 12664272 | Hyperhidrosis | |
126642722 | 12664272 | Liver function test increased | |
126642722 | 12664272 | Swelling |
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 |
---|---|---|---|---|---|---|
126642722 | 12664272 | 1 | 20160717 | 20160803 | 0 | |
126642722 | 12664272 | 2 | 20160706 | 20160716 | 0 | |
126642722 | 12664272 | 3 | 20160804 | 0 | ||
126642722 | 12664272 | 5 | 20160812 | 0 |