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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122450133 | 12245013 | 3 | F | 201603 | 20160514 | 20160407 | 20160726 | EXP | US-UNITED THERAPEUTICS-UNT-2016-005329 | UNITED THERAPEUTICS | 67.95 | YR | F | Y | 82.86000 | KG | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122450133 | 12245013 | 1 | PS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.0597 ?G/KG, CONTINUING | U | U | 2100580 | 21272 | INJECTION | ||||||
| 122450133 | 12245013 | 2 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.0604 ?G/KG, CONTINUING | U | U | 2100701 | 21272 | INJECTION | ||||||
| 122450133 | 12245013 | 3 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.064 ?G/KG, CONTINUING | U | U | 21272 | .064 | UG/KG | INJECTION | |||||
| 122450133 | 12245013 | 4 | SS | REMODULIN | TREPROSTINIL | 1 | Intravenous drip | 0.0645 ?G/KG, CONTINUING | U | U | 2100910 | 21272 | INJECTION | ||||||
| 122450133 | 12245013 | 5 | C | SILDENAFIL. | SILDENAFIL | 1 | 0 | ||||||||||||
| 122450133 | 12245013 | 6 | C | WARFARIN | WARFARIN | 1 | 0 | ||||||||||||
| 122450133 | 12245013 | 7 | C | TRACLEER | BOSENTAN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122450133 | 12245013 | 1 | Pulmonary arterial hypertension |
| 122450133 | 12245013 | 5 | Product used for unknown indication |
| 122450133 | 12245013 | 6 | Product used for unknown indication |
| 122450133 | 12245013 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122450133 | 12245013 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122450133 | 12245013 | Dyspnoea | |
| 122450133 | 12245013 | Fatigue | |
| 122450133 | 12245013 | Nausea | |
| 122450133 | 12245013 | Oedema | |
| 122450133 | 12245013 | Pulmonary arterial hypertension |
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 |
|---|---|---|---|---|---|---|
| 122450133 | 12245013 | 1 | 20150831 | 0 | ||
| 122450133 | 12245013 | 2 | 20160202 | 0 | ||
| 122450133 | 12245013 | 3 | 20160325 | 0 |