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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195297 | 9319529 | 7 | F | 20130831 | 20160629 | 20130530 | 20160705 | EXP | US-GLAXOSMITHKLINE-A0997347A | GLAXOSMITHKLINE | 52.37 | YR | M | Y | 102.00000 | KG | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 93195297 | 9319529 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 1.5 MG VIAL STRENGTH, 30,000 NG/ML CONCENTRATION, CONTINUOUSDOSE: 10 NG/KG/MIN CONTINUOUSLYCONC[...] | U | M600 | 20444 | 6 | DF | POWDER FOR INFUSION | |||||
| 93195297 | 9319529 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N145 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195297 | 9319529 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N644 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195297 | 9319529 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P057 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195297 | 9319529 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P267 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195297 | 9319529 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | P508 | 20444 | POWDER FOR INFUSION | ||||||||
| 93195297 | 9319529 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 48.5 NG/KG/MIN CONTINUOUSLY | U | V934 | 20444 | 48.5 | DF | POWDER FOR INFUSION | ||||||
| 93195297 | 9319529 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 46 NG/KG/MIN, CONTINOUS | U | Z606 | 20444 | 46 | DF | POWDER FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 93195297 | 9319529 | 1 | Cor pulmonale chronic |
| 93195297 | 9319529 | 2 | Pulmonary hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 93195297 | 9319529 | OT |
| 93195297 | 9319529 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 93195297 | 9319529 | Device connection issue | |
| 93195297 | 9319529 | Diarrhoea | |
| 93195297 | 9319529 | Dysentery | |
| 93195297 | 9319529 | Eye swelling | |
| 93195297 | 9319529 | Fatigue | |
| 93195297 | 9319529 | Flushing | |
| 93195297 | 9319529 | Headache | |
| 93195297 | 9319529 | Liver transplant | |
| 93195297 | 9319529 | Malaise | |
| 93195297 | 9319529 | Nausea | |
| 93195297 | 9319529 | Pain in jaw | |
| 93195297 | 9319529 | Rash macular | |
| 93195297 | 9319529 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 93195297 | 9319529 | 1 | 20120831 | 0 | ||
| 93195297 | 9319529 | 2 | 20120831 | 0 | ||
| 93195297 | 9319529 | 3 | 20120831 | 0 | ||
| 93195297 | 9319529 | 4 | 20120831 | 0 | ||
| 93195297 | 9319529 | 5 | 20120831 | 0 | ||
| 93195297 | 9319529 | 6 | 20120831 | 0 | ||
| 93195297 | 9319529 | 7 | 20120830 | 0 | ||
| 93195297 | 9319529 | 8 | 20120830 | 0 |