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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125914532 | 12591453 | 2 | F | 20160203 | 20160607 | 20160726 | 20160727 | PER | US-UNITED THERAPEUTICS-UNT-2016-006557 | UNITED THERAPEUTICS | 52.00 | YR | F | Y | 0.00000 | 20160727 | CN | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125914532 | 12591453 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.04 ?G/KG, CONTINUING | 21272 | .04 | UG/KG | INJECTION | |||||||
125914532 | 12591453 | 2 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | U | 0 | |||||||||
125914532 | 12591453 | 3 | SS | AMBRISENTAN | AMBRISENTAN | 1 | Unknown | 10 MG, QD | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125914532 | 12591453 | 1 | Pulmonary arterial hypertension |
125914532 | 12591453 | 2 | Product used for unknown indication |
125914532 | 12591453 | 3 | Pulmonary hypertension |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125914532 | 12591453 | Diarrhoea | |
125914532 | 12591453 | Dyspnoea exertional | |
125914532 | 12591453 | Headache | |
125914532 | 12591453 | Hyperhidrosis | |
125914532 | 12591453 | Infusion site erythema | |
125914532 | 12591453 | Infusion site infection | |
125914532 | 12591453 | Infusion site pain | |
125914532 | 12591453 | Infusion site pruritus | |
125914532 | 12591453 | Malaise | |
125914532 | 12591453 | Nausea | |
125914532 | 12591453 | Pulmonary arterial hypertension |
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 |
---|---|---|---|---|---|---|
125914532 | 12591453 | 1 | 20151026 | 0 | ||
125914532 | 12591453 | 3 | 20160118 | 0 |