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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100448965 | 10044896 | 5 | F | 20160914 | 20140328 | 20160921 | PER | US-GLAXOSMITHKLINE-A1066393A | GLAXOSMITHKLINE | 0.00 | M | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100448965 | 10044896 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 56 NG/KG/MIN, 75,000 NG/ML | U | R852 | 20444 | 56 | DF | POWDER FOR INJECTION | |||||
| 100448965 | 10044896 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 56 NG/KG/MIN (CONCENTRATION 75,000 NG/ML, PUMP RATE 78 ML/DAY, VIAL STRENGTH 1.5), CO | U | V380 | 20444 | POWDER FOR INJECTION | |||||||
| 100448965 | 10044896 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 56 NG/KG/MIN, CO | U | V785 | 20444 | POWDER FOR INJECTION | ||||||||
| 100448965 | 10044896 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 56 NG/KG/MIN, CO (CONCENTRATION 75,000 NG/ML, PUMP RATE 78 ML/DAY, VIAL STRENGTH 1.5) | U | Z880 | 20444 | 56 | DF | POWDER FOR INJECTION | ||||||
| 100448965 | 10044896 | 5 | SS | Flolan Diluent pH 12 Solution for injection | GLYCINEMANNITOLSODIUM CHLORIDE | 1 | UNK | U | C762537 | 0 | SOLUTION FOR INJECTION | ||||||||
| 100448965 | 10044896 | 6 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 100448965 | 10044896 | 7 | C | ADCIRCA | TADALAFIL | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100448965 | 10044896 | 1 | Cor pulmonale chronic |
| 100448965 | 10044896 | 2 | Pulmonary hypertension |
| 100448965 | 10044896 | 5 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100448965 | 10044896 | HO |
| 100448965 | 10044896 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100448965 | 10044896 | Catheter site erythema | |
| 100448965 | 10044896 | Catheter site infection | |
| 100448965 | 10044896 | Complication associated with device | |
| 100448965 | 10044896 | Device related infection |
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 |
|---|---|---|---|---|---|---|
| 100448965 | 10044896 | 1 | 20050510 | 0 | ||
| 100448965 | 10044896 | 3 | 20050510 | 0 |