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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124617004 | 12461700 | 4 | F | 2016 | 20160818 | 20160613 | 20160825 | EXP | US-UNITED THERAPEUTICS-UNT-2016-009265 | UNITED THERAPEUTICS | 65.67 | YR | F | Y | 74.83000 | KG | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124617004 | 12461700 | 1 | PS | TYVASO | TREPROSTINIL | 1 | 60 ?G, QID | U | U | 2100770 | 22387 | 60 | UG | INHALATION GAS | QID | ||||
| 124617004 | 12461700 | 2 | SS | TYVASO | TREPROSTINIL | 1 | UNK | U | U | 2100817 | 22387 | INHALATION GAS | |||||||
| 124617004 | 12461700 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | U | 0 | |||||||||||
| 124617004 | 12461700 | 4 | SS | ADCIRCA | TADALAFIL | 1 | UNK, QD | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124617004 | 12461700 | 1 | Pulmonary hypertension |
| 124617004 | 12461700 | 3 | Product used for unknown indication |
| 124617004 | 12461700 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124617004 | 12461700 | HO |
| 124617004 | 12461700 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124617004 | 12461700 | Aspiration | |
| 124617004 | 12461700 | Cardiac failure | |
| 124617004 | 12461700 | Dysphagia | |
| 124617004 | 12461700 | Dysplasia | |
| 124617004 | 12461700 | Gastric disorder | |
| 124617004 | 12461700 | Gastrointestinal disorder | |
| 124617004 | 12461700 | Product use issue | |
| 124617004 | 12461700 | Scleroderma |
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 |
|---|---|---|---|---|---|---|
| 124617004 | 12461700 | 1 | 20130322 | 0 |