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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119436372 | 11943637 | 2 | F | 201510 | 20160205 | 20160125 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-012702 | UNITED THERAPEUTICS | 73.24 | YR | F | Y | 86.17000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119436372 | 11943637 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.040 ?G/KG/MIN, CONTINUING | 2100430 | 21272 | .04 | UG/KG | INJECTION | ||||||
| 119436372 | 11943637 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.054 ?G/KG/MIN, CONTINUING | 2100500 | 21272 | .054 | UG/KG | INJECTION | ||||||
| 119436372 | 11943637 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.060 ?G/KG/MIN, CONTINUING | 2100665 | 21272 | .06 | UG/KG | INJECTION | ||||||
| 119436372 | 11943637 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | 0.022 ?G/KG/MIN, CONTINUING | 21272 | .022 | UG/KG | INJECTION | ||||||||
| 119436372 | 11943637 | 5 | C | ADCIRCA | TADALAFIL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119436372 | 11943637 | 1 | Pulmonary arterial hypertension |
| 119436372 | 11943637 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119436372 | 11943637 | Device dislocation | |
| 119436372 | 11943637 | Diarrhoea | |
| 119436372 | 11943637 | Drug dose omission | |
| 119436372 | 11943637 | Infusion site erythema | |
| 119436372 | 11943637 | Infusion site induration | |
| 119436372 | 11943637 | Infusion site oedema | |
| 119436372 | 11943637 | Infusion site pain | |
| 119436372 | 11943637 | Infusion site pruritus | |
| 119436372 | 11943637 | Nausea | |
| 119436372 | 11943637 | Pyrexia |
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 |
|---|---|---|---|---|---|---|
| 119436372 | 11943637 | 1 | 20140513 | 0 |