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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950611 | 12595061 | 1 | I | 201510 | 20151028 | 20160726 | 20160726 | PER | US-UNITED THERAPEUTICS-UNT-2015-013749 | UNITED THERAPEUTICS | 62.85 | YR | F | Y | 68.93000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125950611 | 12595061 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.027 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .027 | UG/KG | INJECTION | ||||
| 125950611 | 12595061 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.007 ?G/KG, CONTINUING | U | U | 2100703 | 21272 | .007 | UG/KG | INJECTION | ||||
| 125950611 | 12595061 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.014 ?G/KG, CONTINUING | U | U | 926117 | 21272 | .014 | UG/KG | INJECTION | ||||
| 125950611 | 12595061 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.040 ?G/KG,CONTIUING | U | U | 926118 | 21272 | .04 | UG/KG | INJECTION | ||||
| 125950611 | 12595061 | 5 | SS | REVATIO | SILDENAFIL CITRATE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125950611 | 12595061 | 6 | C | WARFARIN | WARFARIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125950611 | 12595061 | 1 | Pulmonary arterial hypertension |
| 125950611 | 12595061 | 2 | Pulmonary hypertension |
| 125950611 | 12595061 | 5 | Product used for unknown indication |
| 125950611 | 12595061 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125950611 | 12595061 | Arthralgia | |
| 125950611 | 12595061 | Decreased appetite | |
| 125950611 | 12595061 | Device dislocation | |
| 125950611 | 12595061 | Diarrhoea | |
| 125950611 | 12595061 | Drug dose omission | |
| 125950611 | 12595061 | Headache | |
| 125950611 | 12595061 | Infusion site irritation | |
| 125950611 | 12595061 | Infusion site pruritus | |
| 125950611 | 12595061 | Nausea | |
| 125950611 | 12595061 | Nervousness | |
| 125950611 | 12595061 | Pain in extremity | |
| 125950611 | 12595061 | 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 |
|---|---|---|---|---|---|---|
| 125950611 | 12595061 | 1 | 20150219 | 0 | ||
| 125950611 | 12595061 | 2 | 20151023 | 0 |