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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119440312 | 11944031 | 2 | F | 201509 | 20160127 | 20160125 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-012042 | UNITED THERAPEUTICS | 71.00 | YR | F | Y | 59.86000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119440312 | 11944031 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.006 ?G/KG, CONTINUING | U | U | 2100578 | 21272 | .006 | UG/KG | INJECTION | ||||
| 119440312 | 11944031 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.008 ?G/KG, CONTINUING | U | U | 2100578 | 21272 | .008 | UG/KG | INJECTION | ||||
| 119440312 | 11944031 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.020 ?G/KG, CONTINUING | U | U | 2100703 | 21272 | .02 | UG/KG | INJECTION | ||||
| 119440312 | 11944031 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | 0.0355 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .035 | UG/KG | INJECTION | |||||
| 119440312 | 11944031 | 5 | SS | REMODULIN | TREPROSTINIL | 1 | 0.058 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .058 | UG/KG | INJECTION | |||||
| 119440312 | 11944031 | 6 | SS | REMODULIN | TREPROSTINIL | 1 | 0.066 ?G/KG, CONTINUING | U | U | 926118 | 21272 | .066 | UG/KG | INJECTION | |||||
| 119440312 | 11944031 | 7 | C | REVATIO | SILDENAFIL CITRATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119440312 | 11944031 | 1 | Pulmonary arterial hypertension |
| 119440312 | 11944031 | 7 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119440312 | 11944031 | Diarrhoea | |
| 119440312 | 11944031 | Dyspnoea exertional | |
| 119440312 | 11944031 | Fatigue | |
| 119440312 | 11944031 | Headache | |
| 119440312 | 11944031 | Heart rate increased | |
| 119440312 | 11944031 | Infusion site erythema | |
| 119440312 | 11944031 | Infusion site irritation | |
| 119440312 | 11944031 | Infusion site pain | |
| 119440312 | 11944031 | Myalgia | |
| 119440312 | 11944031 | Nausea | |
| 119440312 | 11944031 | Nervousness | |
| 119440312 | 11944031 | Pain in extremity | |
| 119440312 | 11944031 | Pain in jaw | |
| 119440312 | 11944031 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 119440312 | 11944031 | 1 | 20150916 | 0 |