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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125832411 | 12583241 | 1 | I | 201607 | 20160701 | 20160722 | 20160722 | EXP | US-UNITED THERAPEUTICS-UNT-2016-010794 | UNITED THERAPEUTICS | 34.25 | YR | F | Y | 87.98000 | KG | 20160722 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125832411 | 12583241 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.030 ?G/KG, CONTINUING | U | U | 2100956 | 21272 | .03 | UG/KG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125832411 | 12583241 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125832411 | 12583241 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125832411 | 12583241 | Body temperature increased | |
| 125832411 | 12583241 | Fluid overload | |
| 125832411 | 12583241 | Infusion site induration | |
| 125832411 | 12583241 | Infusion site infection | |
| 125832411 | 12583241 | Infusion site pain |
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 |
|---|---|---|---|---|---|---|
| 125832411 | 12583241 | 1 | 20160325 | 0 |