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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123990343 | 12399034 | 3 | F | 20160502 | 20160715 | 20160524 | 20160722 | EXP | US-UNITED THERAPEUTICS-UNT-2016-007326 | UNITED THERAPEUTICS | 19.76 | YR | M | Y | 67.12000 | KG | 20160722 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123990343 | 12399034 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.192 ?G/KG, CONTINUING | U | U | 2100701 | 21272 | .192 | UG/KG | INJECTION | ||||
| 123990343 | 12399034 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.207 ?G/KG, CONTINUING | U | U | 21272 | .207 | UG/KG | INJECTION | |||||
| 123990343 | 12399034 | 3 | C | ADCIRCA | TADALAFIL | 1 | 0 | ||||||||||||
| 123990343 | 12399034 | 4 | C | COUMADIN | WARFARIN SODIUM | 1 | 0 | ||||||||||||
| 123990343 | 12399034 | 5 | C | OPSUMIT | MACITENTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123990343 | 12399034 | 1 | Pulmonary arterial hypertension |
| 123990343 | 12399034 | 3 | Product used for unknown indication |
| 123990343 | 12399034 | 4 | Product used for unknown indication |
| 123990343 | 12399034 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123990343 | 12399034 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123990343 | 12399034 | Pericardial effusion | |
| 123990343 | 12399034 | Pulmonary arterial hypertension | |
| 123990343 | 12399034 | Surgery |
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 |
|---|---|---|---|---|---|---|
| 123990343 | 12399034 | 1 | 20150616 | 0 |