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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124881826 | 12488182 | 6 | F | 20160604 | 20160815 | 20160622 | 20160823 | EXP | US-UNITED THERAPEUTICS-UNT-2016-009182 | UNITED THERAPEUTICS | 56.83 | YR | M | Y | 78.50000 | KG | 20160823 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124881826 | 12488182 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.030 ?G/KG, CONTINUING | 2100910 | 21272 | .03 | UG/KG | INJECTION | ||||||
| 124881826 | 12488182 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Subcutaneous | 0.032 ?G/KG, CONTINUING | 929006 | 21272 | .032 | UG/KG | INJECTION | ||||||
| 124881826 | 12488182 | 3 | C | OPSUMIT | MACITENTAN | 1 | 0 | ||||||||||||
| 124881826 | 12488182 | 4 | C | ADCIRCA | TADALAFIL | 1 | 0 | ||||||||||||
| 124881826 | 12488182 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124881826 | 12488182 | 1 | Pulmonary hypertension |
| 124881826 | 12488182 | 3 | Product used for unknown indication |
| 124881826 | 12488182 | 4 | Product used for unknown indication |
| 124881826 | 12488182 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124881826 | 12488182 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124881826 | 12488182 | Diarrhoea | |
| 124881826 | 12488182 | Dyspnoea | |
| 124881826 | 12488182 | Fluid overload | |
| 124881826 | 12488182 | Fluid retention | |
| 124881826 | 12488182 | Gait disturbance | |
| 124881826 | 12488182 | Infusion site infection | |
| 124881826 | 12488182 | Oedema peripheral |
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 |
|---|---|---|---|---|---|---|
| 124881826 | 12488182 | 1 | 20100517 | 201608 | 0 |