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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950351 | 12595035 | 1 | I | 20151117 | 20151118 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-014746 | UNITED THERAPEUTICS | 74.76 | YR | F | Y | 73.16000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950351 | 12595035 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.022 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .022 | UG/KG | INJECTION | ||||
| 125950351 | 12595035 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.030 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .03 | UG/KG | INJECTION | ||||
| 125950351 | 12595035 | 3 | SS | LETAIRIS | AMBRISENTAN | 1 | Unknown | 5 MG, QD | NZYD | 0 | 5 | MG | TABLET | QD | |||||
| 125950351 | 12595035 | 4 | SS | ADCIRCA | TADALAFIL | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125950351 | 12595035 | 1 | Pulmonary arterial hypertension |
| 125950351 | 12595035 | 3 | Product used for unknown indication |
| 125950351 | 12595035 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125950351 | 12595035 | Decreased appetite | |
| 125950351 | 12595035 | Device dislocation | |
| 125950351 | 12595035 | Drug dose omission | |
| 125950351 | 12595035 | Fatigue | |
| 125950351 | 12595035 | Infusion site erythema | |
| 125950351 | 12595035 | Infusion site oedema | |
| 125950351 | 12595035 | Infusion site pain | |
| 125950351 | 12595035 | Nausea | |
| 125950351 | 12595035 | Oedema peripheral | |
| 125950351 | 12595035 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 125950351 | 12595035 | 1 | 20150904 | 0 | ||
| 125950351 | 12595035 | 2 | 20150904 | 0 | ||
| 125950351 | 12595035 | 3 | 20141118 | 0 |