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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125913982 | 12591398 | 2 | F | 201601 | 20160122 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2016-000061 | UNITED THERAPEUTICS | 65.25 | YR | M | Y | 70.30000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125913982 | 12591398 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.039 ?G/KG/MIN, CONTINUING | U | U | 926118 | 21272 | .039 | UG/KG | INJECTION | ||||
| 125913982 | 12591398 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.057 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .057 | UG/KG | INJECTION | ||||
| 125913982 | 12591398 | 3 | C | ADEMPAS | RIOCIGUAT | 1 | 0 | ||||||||||||
| 125913982 | 12591398 | 4 | C | WARFARIN | WARFARIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125913982 | 12591398 | 1 | Pulmonary hypertension |
| 125913982 | 12591398 | 3 | Product used for unknown indication |
| 125913982 | 12591398 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125913982 | 12591398 | Device dislocation | |
| 125913982 | 12591398 | Infusion site erythema | |
| 125913982 | 12591398 | Infusion site irritation | |
| 125913982 | 12591398 | Infusion site pain | |
| 125913982 | 12591398 | Insomnia | |
| 125913982 | 12591398 | Pain in extremity | |
| 125913982 | 12591398 | Pain in jaw | |
| 125913982 | 12591398 | Therapy cessation |
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 |
|---|---|---|---|---|---|---|
| 125913982 | 12591398 | 1 | 20150929 | 0 |