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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945011 | 12594501 | 1 | I | 20151014 | 20151221 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016237 | UNITED THERAPEUTICS | 61.00 | YR | F | Y | 68.27000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945011 | 12594501 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 11 MG, BID | Y | 2100397 | 203496 | 11 | MG | TABLET | BID | ||||
| 125945011 | 12594501 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 11 MG, BID | Y | 2100399 | 203496 | 11 | MG | TABLET | BID | ||||
| 125945011 | 12594501 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | Y | 2100398 | 203496 | TABLET | |||||||
| 125945011 | 12594501 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 12 MG, BID | Y | 2100398 | 203496 | 12 | MG | TABLET | BID | ||||
| 125945011 | 12594501 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 11 MG, TID | Y | 2100397 | 203496 | 11 | MG | TABLET | TID | ||||
| 125945011 | 12594501 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 10 MG, BID | Y | 2100477 | 203496 | 10 | MG | TABLET | BID | ||||
| 125945011 | 12594501 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | Y | 2100679 | 203496 | TABLET | ||||||||
| 125945011 | 12594501 | 8 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 10 MG, QD | SBFX | 0 | 10 | MG | TABLET | QD | |||||
| 125945011 | 12594501 | 9 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | UNK | 1500226A | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125945011 | 12594501 | 1 | Pulmonary hypertension |
| 125945011 | 12594501 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125945011 | 12594501 | Decreased appetite | |
| 125945011 | 12594501 | Diarrhoea | |
| 125945011 | 12594501 | Dizziness | |
| 125945011 | 12594501 | Faeces soft | |
| 125945011 | 12594501 | Flushing | |
| 125945011 | 12594501 | Hypophagia | |
| 125945011 | 12594501 | Malaise | |
| 125945011 | 12594501 | Nausea | |
| 125945011 | 12594501 | Vomiting projectile |
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 |
|---|---|---|---|---|---|---|
| 125945011 | 12594501 | 1 | 20150717 | 0 | ||
| 125945011 | 12594501 | 8 | 20130325 | 0 |