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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945061 | 12594506 | 1 | I | 20151130 | 20151217 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016104 | UNITED THERAPEUTICS | 31.92 | YR | F | Y | 163.26000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125945061 | 12594506 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.3 MG, TID | U | U | 2100368 | 203496 | .3 | MG | TABLET | TID | |||
| 125945061 | 12594506 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 2100397 | 203496 | TABLET | ||||||
| 125945061 | 12594506 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.125 MG, TID | U | U | 2100371 | 203496 | .125 | MG | TABLET | TID | |||
| 125945061 | 12594506 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.375 MG,TID | U | U | 2100368 | 203496 | .375 | MG | TABLET | TID | |||
| 125945061 | 12594506 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.375 MG, Q8H | U | U | 2100368 | 203496 | .375 | MG | TABLET | TID | |||
| 125945061 | 12594506 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | U | U | 210036 | 203496 | TABLET | ||||||
| 125945061 | 12594506 | 7 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.5 MG, TID | U | U | 210036 | 203496 | .5 | MG | TABLET | TID | |||
| 125945061 | 12594506 | 8 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | SBFX | 0 | 10 | MG | TABLET | QD | |||||
| 125945061 | 12594506 | 9 | SS | LETAIRIS | AMBRISENTAN | 1 | UNK | SBFW | 0 | TABLET | |||||||||
| 125945061 | 12594506 | 10 | C | ADCIRCA | TADALAFIL | 1 | Unknown | 0 | |||||||||||
| 125945061 | 12594506 | 11 | C | WARFARIN | WARFARIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125945061 | 12594506 | 1 | Pulmonary hypertension |
| 125945061 | 12594506 | 2 | Pulmonary arterial hypertension |
| 125945061 | 12594506 | 8 | Product used for unknown indication |
| 125945061 | 12594506 | 10 | Product used for unknown indication |
| 125945061 | 12594506 | 11 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125945061 | 12594506 | Abdominal discomfort | |
| 125945061 | 12594506 | Diarrhoea | |
| 125945061 | 12594506 | Flushing | |
| 125945061 | 12594506 | Headache | |
| 125945061 | 12594506 | Nasal congestion | |
| 125945061 | 12594506 | Nausea | |
| 125945061 | 12594506 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125945061 | 12594506 | 1 | 20151130 | 0 | ||
| 125945061 | 12594506 | 3 | 20151211 | 0 | ||
| 125945061 | 12594506 | 4 | 20151230 | 0 | ||
| 125945061 | 12594506 | 8 | 20150522 | 0 | ||
| 125945061 | 12594506 | 9 | 20150520 | 0 |