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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125951401 | 12595140 | 1 | I | 20151228 | 20160112 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-000769 | UNITED THERAPEUTICS | 43.55 | YR | F | Y | 117.91000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125951401 | 12595140 | 1 | PS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.25 MG, TID | U | U | 2100397 | 203496 | .25 | MG | TABLET | TID | |||
| 125951401 | 12595140 | 2 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 0.75 MG, TID | U | U | 2100684 | 203496 | .75 | MG | TABLET | TID | |||
| 125951401 | 12595140 | 3 | SS | ORENITRAM | TREPROSTINIL | 1 | Oral | 1.375 MG, TID | U | U | 2100477 | 203496 | 1.375 | MG | TABLET | TID | |||
| 125951401 | 12595140 | 4 | SS | ORENITRAM | TREPROSTINIL | 1 | UNK | U | U | 2100684 | 203496 | TABLET | |||||||
| 125951401 | 12595140 | 5 | SS | LETAIRIS | AMBRISENTAN | 1 | Oral | 10 MG, QD | 1500226A | 0 | 10 | MG | TABLET | QD | |||||
| 125951401 | 12595140 | 6 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125951401 | 12595140 | 1 | Pulmonary arterial hypertension |
| 125951401 | 12595140 | 5 | Product used for unknown indication |
| 125951401 | 12595140 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125951401 | 12595140 | Diarrhoea | |
| 125951401 | 12595140 | Dyspnoea exertional | |
| 125951401 | 12595140 | Flushing | |
| 125951401 | 12595140 | Headache | |
| 125951401 | 12595140 | Nausea | |
| 125951401 | 12595140 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125951401 | 12595140 | 1 | 20151228 | 0 | ||
| 125951401 | 12595140 | 5 | 20141029 | 0 |