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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105251774 | 10525177 | 4 | F | 20141003 | 20160803 | 20141017 | 20160810 | EXP | US-GLAXOSMITHKLINE-US2014GSK007261 | GLAXOSMITHKLINE | 48.23 | YR | F | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105251774 | 10525177 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | UNK, CO | U | S707 | 20444 | POWDER FOR INFUSION | |||||||
| 105251774 | 10525177 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | T274 | 20444 | POWDER FOR INFUSION | ||||||||
| 105251774 | 10525177 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 36NG/KG/MIN (CONCENTRATION 45,000 NG/ML, PUMP RATE 94 ML/DAY, VIAL STRENGTH 1.5 MG), CO | U | V785 | 20444 | POWDER FOR INFUSION | |||||||
| 105251774 | 10525177 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 36 NG/KG/MIN, CONTINUOUSLY | U | Z880 | 20444 | 36 | DF | POWDER FOR INFUSION | ||||||
| 105251774 | 10525177 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | U | 0 | SOLUTION FOR INJECTION | ||||||||||
| 105251774 | 10525177 | 6 | C | WARFARIN | WARFARIN | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105251774 | 10525177 | 1 | Cor pulmonale chronic |
| 105251774 | 10525177 | 2 | Atrial septal defect |
| 105251774 | 10525177 | 3 | Pulmonary hypertension |
| 105251774 | 10525177 | 5 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105251774 | 10525177 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105251774 | 10525177 | Abdominal discomfort | |
| 105251774 | 10525177 | Complication associated with device | |
| 105251774 | 10525177 | Feeling abnormal | |
| 105251774 | 10525177 | Medical device change | |
| 105251774 | 10525177 | Product quality issue |
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 |
|---|---|---|---|---|---|---|
| 105251774 | 10525177 | 1 | 20040526 | 0 | ||
| 105251774 | 10525177 | 4 | 20040526 | 0 |