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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124678744 | 12467874 | 4 | F | 2016 | 20160720 | 20160615 | 20160808 | EXP | US-UNITED THERAPEUTICS-UNT-2016-007250 | UNITED THERAPEUTICS | 55.27 | YR | M | Y | 77.69000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124678744 | 12467874 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.029 ?G/KG, CONTINUING | U | U | 926618 | 21272 | .029 | UG/KG | INJECTION | ||||
| 124678744 | 12467874 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.015 ?G/KG, CONTINUING | U | U | 926619 | 21272 | .015 | UG/KG | INJECTION | ||||
| 124678744 | 12467874 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.02 ?G/KG, CONTINUING | U | U | 2100956 | 21272 | .02 | UG/KG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124678744 | 12467874 | 1 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124678744 | 12467874 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124678744 | 12467874 | Abdominal distension | |
| 124678744 | 12467874 | Amnesia | |
| 124678744 | 12467874 | Decreased appetite | |
| 124678744 | 12467874 | Diarrhoea | |
| 124678744 | 12467874 | Dysgeusia | |
| 124678744 | 12467874 | Fall | |
| 124678744 | 12467874 | Hepatic cirrhosis | |
| 124678744 | 12467874 | Hepatic pain | |
| 124678744 | 12467874 | Infusion site erythema | |
| 124678744 | 12467874 | Infusion site infection | |
| 124678744 | 12467874 | Infusion site oedema | |
| 124678744 | 12467874 | Infusion site pain | |
| 124678744 | 12467874 | Infusion site pruritus | |
| 124678744 | 12467874 | Infusion site warmth | |
| 124678744 | 12467874 | Nausea | |
| 124678744 | 12467874 | Oedema | |
| 124678744 | 12467874 | Oesophageal disorder | |
| 124678744 | 12467874 | Pain | |
| 124678744 | 12467874 | Rash | |
| 124678744 | 12467874 | Trismus | |
| 124678744 | 12467874 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124678744 | 12467874 | 1 | 20160209 | 2016 | 0 |