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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125417543 | 12541754 | 3 | F | 20160405 | 20160825 | 20160708 | 20160831 | EXP | US-UNITED THERAPEUTICS-UNT-2016-010866 | UNITED THERAPEUTICS | 53.89 | YR | M | Y | 0.00000 | 20160831 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125417543 | 12541754 | 1 | PS | TYVASO | TREPROSTINIL | 1 | 72 ?G, QID | U | U | 22387 | 72 | UG | INHALATION GAS | QID | |||||
| 125417543 | 12541754 | 2 | SS | BLINDED Beraprost Sodium | BERAPROST SODIUM | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 125417543 | 12541754 | 3 | SS | BLINDED Placebo | INVESTIGATIONAL PRODUCT | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 125417543 | 12541754 | 4 | C | KLOR-CON | POTASSIUM CHLORIDE | 1 | Oral | 40 MEQ, TID | 0 | 40 | MEQ | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125417543 | 12541754 | 1 | Pulmonary arterial hypertension |
| 125417543 | 12541754 | 2 | Pulmonary arterial hypertension |
| 125417543 | 12541754 | 3 | Pulmonary arterial hypertension |
| 125417543 | 12541754 | 4 | Blood potassium decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125417543 | 12541754 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125417543 | 12541754 | Electrocardiogram QT prolonged | |
| 125417543 | 12541754 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125417543 | 12541754 | 2 | 20160113 | 0 | ||
| 125417543 | 12541754 | 3 | 20160113 | 0 | ||
| 125417543 | 12541754 | 4 | 2012 | 0 |