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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118789293 | 11878929 | 3 | F | 20160909 | 20151230 | 20160914 | EXP | US-GLAXOSMITHKLINE-US2015GSK183083 | GLAXOSMITHKLINE | 0.00 | M | Y | 0.00000 | 20160914 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118789293 | 11878929 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 35 NG/KG/MIN CO (CONCENTRATION: 60,000 NG/ML, PUMP RATE: 76 ML/DAY, VIAL STRENGTH: 1.5 MG) | U | V785 | 20444 | POWDER FOR INFUSION | |||||||
| 118789293 | 11878929 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 35 NG/KG/MIN, CO | U | Z880 | 20444 | 35 | DF | POWDER FOR INFUSION | |||||
| 118789293 | 11878929 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | C762537 | 0 | SOLUTION FOR INJECTION | |||||||||
| 118789293 | 11878929 | 4 | C | OPSUMIT | MACITENTAN | 1 | U | 0 | |||||||||||
| 118789293 | 11878929 | 5 | C | SILDENAFIL CITRATE. | SILDENAFIL CITRATE | 1 | U | 0 | |||||||||||
| 118789293 | 11878929 | 6 | C | WARFARIN | WARFARIN | 1 | U | 0 | |||||||||||
| 118789293 | 11878929 | 7 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118789293 | 11878929 | 1 | Pulmonary arterial hypertension |
| 118789293 | 11878929 | 3 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118789293 | 11878929 | OT |
| 118789293 | 11878929 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118789293 | 11878929 | Adverse event | |
| 118789293 | 11878929 | Catheter management | |
| 118789293 | 11878929 | Catheter removal | |
| 118789293 | 11878929 | Complication associated with device | |
| 118789293 | 11878929 | Device alarm issue | |
| 118789293 | 11878929 | Diagnostic procedure | |
| 118789293 | 11878929 | Hospitalisation |
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 |
|---|---|---|---|---|---|---|
| 118789293 | 11878929 | 1 | 20071115 | 0 |