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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125913052 | 12591305 | 2 | F | 201504 | 20160520 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-016212 | UNITED THERAPEUTICS | 36.68 | YR | F | Y | 94.79000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125913052 | 12591305 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | UNK | U | U | 21272 | INJECTION | |||||||
| 125913052 | 12591305 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.048 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .048 | UG/KG | INJECTION | ||||
| 125913052 | 12591305 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.050 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .05 | UG/KG | INJECTION | ||||
| 125913052 | 12591305 | 4 | C | TRACLEER | BOSENTAN | 1 | U | U | 0 | ||||||||||
| 125913052 | 12591305 | 5 | C | ADCIRCA | TADALAFIL | 1 | U | U | 0 | ||||||||||
| 125913052 | 12591305 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125913052 | 12591305 | 1 | Pulmonary hypertension |
| 125913052 | 12591305 | 2 | Pulmonary arterial hypertension |
| 125913052 | 12591305 | 4 | Product used for unknown indication |
| 125913052 | 12591305 | 5 | Product used for unknown indication |
| 125913052 | 12591305 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125913052 | 12591305 | Chest pain | |
| 125913052 | 12591305 | Dermatitis contact | |
| 125913052 | 12591305 | Device dislocation | |
| 125913052 | 12591305 | Drug dose omission | |
| 125913052 | 12591305 | Hypersensitivity | |
| 125913052 | 12591305 | Infection | |
| 125913052 | 12591305 | Injection site discharge | |
| 125913052 | 12591305 | Laceration | |
| 125913052 | 12591305 | Malaise | |
| 125913052 | 12591305 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 125913052 | 12591305 | 1 | 20150423 | 0 | ||
| 125913052 | 12591305 | 2 | 20150504 | 0 | ||
| 125913052 | 12591305 | 3 | 20150504 | 0 |