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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125916791 | 12591679 | 1 | I | 201601 | 20160201 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-001647 | UNITED THERAPEUTICS | 65.18 | YR | F | Y | 79.82000 | KG | 20160726 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125916791 | 12591679 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 4 MG, TID | U | U | 2100397 | 203496 | 4 | MG | TABLET | TID | |||
125916791 | 12591679 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100398 | 203496 | TABLET | ||||||
125916791 | 12591679 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 5 MG, QD | SBFP | 0 | 5 | MG | TABLET | QD | |||||
125916791 | 12591679 | 4 | SS | SILDENAFIL. | SILDENAFIL | 1 | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125916791 | 12591679 | 1 | Pulmonary hypertension |
125916791 | 12591679 | 3 | Product used for unknown indication |
125916791 | 12591679 | 4 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125916791 | 12591679 | Abdominal discomfort | |
125916791 | 12591679 | Drug dose omission |
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 |
---|---|---|---|---|---|---|
125916791 | 12591679 | 1 | 20141016 | 0 | ||
125916791 | 12591679 | 3 | 20150624 | 0 |