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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931962513 | 9319625 | 13 | F | 201302 | 20160708 | 20130530 | 20160713 | EXP | US-GLAXOSMITHKLINE-A1015553A | GLAXOSMITHKLINE | 52.64 | YR | M | Y | 71.00000 | KG | 20160713 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 931962513 | 9319625 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 36.5 NG/KG/MIN38 NG/KG/MIN, CONCENTRATION 60,000 NG/ML, PUMP RATE 61 ML/DAY, VIAL STRENGTH 1.5 MG | U | N437 | 20444 | 36.5 | DF | POWDER FOR INFUSION | |||||
| 931962513 | 9319625 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N849 | 20444 | POWDER FOR INFUSION | ||||||||
| 931962513 | 9319625 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | S501 | 20444 | POWDER FOR INFUSION | ||||||||
| 931962513 | 9319625 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | C672809 | 20444 | POWDER FOR INFUSION | ||||||||
| 931962513 | 9319625 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 42 NG/KG/MIN, CONTINUOUS | U | W663 | 20444 | 42 | DF | POWDER FOR INFUSION | ||||||
| 931962513 | 9319625 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 43 NG/KG/MIN, CONTINUOUS | U | Z606 | 20444 | 43 | DF | POWDER FOR INFUSION | ||||||
| 931962513 | 9319625 | 7 | C | SILDENAFIL. | SILDENAFIL | 1 | U | 0 | |||||||||||
| 931962513 | 9319625 | 8 | C | COUMADIN | WARFARIN SODIUM | 1 | U | 0 | |||||||||||
| 931962513 | 9319625 | 9 | C | TRACLEER | BOSENTAN | 1 | U | 0 | |||||||||||
| 931962513 | 9319625 | 10 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 931962513 | 9319625 | 1 | Cor pulmonale chronic |
| 931962513 | 9319625 | 2 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 931962513 | 9319625 | OT |
| 931962513 | 9319625 | DE |
| 931962513 | 9319625 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 931962513 | 9319625 | Catheter site infection | |
| 931962513 | 9319625 | Central venous catheterisation | |
| 931962513 | 9319625 | Critical illness | |
| 931962513 | 9319625 | Device breakage | |
| 931962513 | 9319625 | Device related infection | |
| 931962513 | 9319625 | Device related sepsis | |
| 931962513 | 9319625 | Diarrhoea | |
| 931962513 | 9319625 | Dyspnoea | |
| 931962513 | 9319625 | Endotracheal intubation | |
| 931962513 | 9319625 | Flushing | |
| 931962513 | 9319625 | Headache | |
| 931962513 | 9319625 | Mechanical ventilation | |
| 931962513 | 9319625 | Multiple organ dysfunction syndrome | |
| 931962513 | 9319625 | Oedema | |
| 931962513 | 9319625 | Pain in extremity | |
| 931962513 | 9319625 | Pain in jaw | |
| 931962513 | 9319625 | Platelet count decreased | |
| 931962513 | 9319625 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 931962513 | 9319625 | 1 | 20120213 | 0 | ||
| 931962513 | 9319625 | 2 | 20120213 | 0 | ||
| 931962513 | 9319625 | 3 | 20120213 | 0 | ||
| 931962513 | 9319625 | 4 | 20120213 | 0 | ||
| 931962513 | 9319625 | 5 | 20120213 | 0 | ||
| 931962513 | 9319625 | 6 | 20120213 | 0 |