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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125951431 | 12595143 | 1 | I | 201601 | 20160128 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-001416 | UNITED THERAPEUTICS | 48.41 | YR | F | Y | 73.16000 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125951431 | 12595143 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 4 MG, BID | U | U | 2100397 | 203496 | 4 | MG | TABLET | BID | |||
125951431 | 12595143 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100398 | 203496 | TABLET | ||||||
125951431 | 12595143 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100399 | 203496 | TABLET | ||||||
125951431 | 12595143 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100476 | 203496 | TABLET | ||||||
125951431 | 12595143 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100477 | 203496 | TABLET | ||||||
125951431 | 12595143 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100679 | 203496 | TABLET | ||||||
125951431 | 12595143 | 7 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1500227A | 0 | 10 | MG | TABLET | QD | |||||
125951431 | 12595143 | 8 | SS | LETAIRIS | AMBRISENTAN | 1 | 0 | TABLET | |||||||||||
125951431 | 12595143 | 9 | C | NIFEDIPINE. | NIFEDIPINE | 1 | U | U | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125951431 | 12595143 | 1 | Pulmonary hypertension |
125951431 | 12595143 | 7 | Pulmonary hypertension |
125951431 | 12595143 | 8 | Scleroderma |
125951431 | 12595143 | 9 | Product used for unknown indication |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125951431 | 12595143 | Dizziness | |
125951431 | 12595143 | Dyspnoea | |
125951431 | 12595143 | Muscular weakness | |
125951431 | 12595143 | Palpitations |
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 |
---|---|---|---|---|---|---|
125951431 | 12595143 | 1 | 20150422 | 0 | ||
125951431 | 12595143 | 7 | 20120201 | 0 |