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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125909612 | 12590961 | 2 | F | 20151202 | 20160202 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-015315 | UNITED THERAPEUTICS | 66.17 | YR | F | Y | 56.69000 | KG | 20160726 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125909612 | 12590961 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous (not otherwise specified) | 0.140 ?G/KG, CONTINUING | 926118 | 21272 | .14 | UG/KG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125909612 | 12590961 | 1 | Pulmonary arterial hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125909612 | 12590961 | Chills | |
| 125909612 | 12590961 | Device leakage | |
| 125909612 | 12590961 | Diarrhoea | |
| 125909612 | 12590961 | Drug dose omission | |
| 125909612 | 12590961 | Epistaxis | |
| 125909612 | 12590961 | Head discomfort | |
| 125909612 | 12590961 | Malaise | |
| 125909612 | 12590961 | Nasal congestion | |
| 125909612 | 12590961 | Nasopharyngitis | |
| 125909612 | 12590961 | Pain in jaw | |
| 125909612 | 12590961 | Sinus pain | |
| 125909612 | 12590961 | Thrombosis in device |
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 |
|---|---|---|---|---|---|---|
| 125909612 | 12590961 | 1 | 20130211 | 0 |