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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950551 | 12595055 | 1 | I | 20151229 | 20160107 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-000306 | UNITED THERAPEUTICS | 42.89 | YR | F | Y | 70.30000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950551 | 12595055 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 6 MG, Q8H WITH FOOD | U | U | 2100398 | 203496 | 6 | MG | TABLET | TID | |||
| 125950551 | 12595055 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 6 MG, TID, ORAL | U | U | 2100398 | 203496 | 6 | MG | TABLET | TID | |||
| 125950551 | 12595055 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | U | U | 2100399 | 203496 | TABLET | |||||||
| 125950551 | 12595055 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.016 ?G/KG, CONTINUING | U | U | 924714 | 0 | .016 | UG/KG | INJECTION | ||||
| 125950551 | 12595055 | 5 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | SBFW | 0 | 10 | MG | TABLET | QD | |||||
| 125950551 | 12595055 | 6 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125950551 | 12595055 | 1 | Pulmonary arterial hypertension |
| 125950551 | 12595055 | 4 | Product used for unknown indication |
| 125950551 | 12595055 | 5 | Product used for unknown indication |
| 125950551 | 12595055 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125950551 | 12595055 | Dyspnoea | |
| 125950551 | 12595055 | Fall | |
| 125950551 | 12595055 | Ligament sprain | |
| 125950551 | 12595055 | 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 |
|---|---|---|---|---|---|---|
| 125950551 | 12595055 | 1 | 20141230 | 0 | ||
| 125950551 | 12595055 | 4 | 20140508 | 0 | ||
| 125950551 | 12595055 | 5 | 20130722 | 0 |