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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945001 | 12594500 | 1 | I | 20151218 | 20151219 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016132 | UNITED THERAPEUTICS | 18.05 | YR | F | Y | 49.89000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945001 | 12594500 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 2.5 MG, Q12H WITH FOOD | Y | 2100399 | 203496 | 2.5 | MG | TABLET | BID | ||||
| 125945001 | 12594500 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | 2100679 | 203496 | TABLET | ||||||||
| 125945001 | 12594500 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG,QD | SBFX | 0 | 10 | MG | TABLET | QD | |||||
| 125945001 | 12594500 | 4 | SS | LETAIRIS | AMBRISENTAN | 1 | UNK | 1500225A | 0 | TABLET | |||||||||
| 125945001 | 12594500 | 5 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125945001 | 12594500 | 1 | Pulmonary arterial hypertension |
| 125945001 | 12594500 | 3 | Pulmonary arterial hypertension |
| 125945001 | 12594500 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125945001 | 12594500 | Diarrhoea | |
| 125945001 | 12594500 | Dyspepsia | |
| 125945001 | 12594500 | Fear | |
| 125945001 | 12594500 | Flushing | |
| 125945001 | 12594500 | Incorrect dose administered | |
| 125945001 | 12594500 | Malaise | |
| 125945001 | 12594500 | Nausea | |
| 125945001 | 12594500 | 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 |
|---|---|---|---|---|---|---|
| 125945001 | 12594500 | 1 | 20150727 | 0 | ||
| 125945001 | 12594500 | 3 | 20140419 | 0 |