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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125910991 | 12591099 | 1 | I | 201510 | 20151026 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-013636 | UNITED THERAPEUTICS | 64.52 | YR | F | Y | 73.47000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125910991 | 12591099 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 4 MG, TID | 2100397 | 203496 | 4 | MG | TABLET | TID | |||||
| 125910991 | 12591099 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | UNK | 2100398 | 203496 | TABLET | ||||||||
| 125910991 | 12591099 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 4.25 MG, TID | 2100397 | 203496 | 4.25 | MG | TABLET | TID | |||||
| 125910991 | 12591099 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5 MG, TID | 203496 | 5 | MG | TABLET | TID | ||||||
| 125910991 | 12591099 | 5 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | 2100399 | 203496 | TABLET | |||||||||
| 125910991 | 12591099 | 6 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 5.25MG, TID | 203496 | 5.25 | MG | TABLET | TID | ||||||
| 125910991 | 12591099 | 7 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | Y | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125910991 | 12591099 | 1 | Pulmonary hypertension |
| 125910991 | 12591099 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125910991 | 12591099 | Asthenia | |
| 125910991 | 12591099 | Blood pressure diastolic decreased | |
| 125910991 | 12591099 | Dyspnoea exertional | |
| 125910991 | 12591099 | Fatigue | |
| 125910991 | 12591099 | Headache | |
| 125910991 | 12591099 | Infusion site infection | |
| 125910991 | 12591099 | Malaise | |
| 125910991 | 12591099 | Musculoskeletal discomfort | |
| 125910991 | 12591099 | Presyncope |
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 |
|---|---|---|---|---|---|---|
| 125910991 | 12591099 | 1 | 20150128 | 0 | ||
| 125910991 | 12591099 | 4 | 20150128 | 0 |