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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126548411 | 12654841 | 1 | I | 20150416 | 20160809 | 20160816 | 20160816 | EXP | US-GLAXOSMITHKLINE-US2016GSK115987 | GLAXOSMITHKLINE | 70.00 | YR | M | Y | 114.00000 | KG | 20160816 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126548411 | 12654841 | 1 | PS | COREG | CARVEDILOL | 1 | UNK | 20297 | |||||||||||
| 126548411 | 12654841 | 2 | SS | ENZALUTAMIDE | ENZALUTAMIDE | 1 | Oral | 160 MG, QD | 15680 | MG | 0 | 160 | MG | QD | |||||
| 126548411 | 12654841 | 3 | SS | ENZALUTAMIDE | ENZALUTAMIDE | 1 | Oral | 160 MG, QD | 15680 | MG | 0 | 160 | MG | QD | |||||
| 126548411 | 12654841 | 4 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 1000 MG, QD | 98000 | MG | 0 | 1000 | MG | QD | |||||
| 126548411 | 12654841 | 5 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 1000 MG, QD | 98000 | MG | 0 | 1000 | MG | QD | |||||
| 126548411 | 12654841 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 126548411 | 12654841 | 7 | SS | ATORVASTATIN | ATORVASTATIN | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 8 | SS | ASPIRIN. | ASPIRIN | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 9 | SS | CALCIUM + COLECALCIFEROL | CALCIUMCHOLECALCIFEROL | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 10 | SS | DENOSUMAB | DENOSUMAB | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 11 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 12 | SS | ENALAPRIL | ENALAPRIL | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 13 | SS | TAMSULOSIN | TAMSULOSIN | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 14 | SS | HUMALOG | INSULIN LISPRO | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 15 | SS | LANTUS | INSULIN GLARGINE | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 16 | SS | ZOLADEX | GOSERELIN ACETATE | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 17 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126548411 | 12654841 | 18 | SS | EXENATIDE | EXENATIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126548411 | 12654841 | 1 | Product used for unknown indication |
| 126548411 | 12654841 | 2 | Hormone-refractory prostate cancer |
| 126548411 | 12654841 | 4 | Hormone-refractory prostate cancer |
| 126548411 | 12654841 | 6 | Hormone-refractory prostate cancer |
| 126548411 | 12654841 | 7 | Product used for unknown indication |
| 126548411 | 12654841 | 8 | Product used for unknown indication |
| 126548411 | 12654841 | 9 | Product used for unknown indication |
| 126548411 | 12654841 | 10 | Product used for unknown indication |
| 126548411 | 12654841 | 11 | Product used for unknown indication |
| 126548411 | 12654841 | 12 | Product used for unknown indication |
| 126548411 | 12654841 | 13 | Product used for unknown indication |
| 126548411 | 12654841 | 14 | Product used for unknown indication |
| 126548411 | 12654841 | 15 | Product used for unknown indication |
| 126548411 | 12654841 | 16 | Product used for unknown indication |
| 126548411 | 12654841 | 17 | Product used for unknown indication |
| 126548411 | 12654841 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126548411 | 12654841 | HO |
| 126548411 | 12654841 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126548411 | 12654841 | Abdominal pain | |
| 126548411 | 12654841 | Acute kidney injury | |
| 126548411 | 12654841 | Cardiac failure congestive | |
| 126548411 | 12654841 | Cholecystitis acute | |
| 126548411 | 12654841 | Decreased appetite | |
| 126548411 | 12654841 | Pancreatitis acute |
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 |
|---|---|---|---|---|---|---|
| 126548411 | 12654841 | 2 | 20150108 | 20150715 | 0 | |
| 126548411 | 12654841 | 3 | 20150806 | 0 | ||
| 126548411 | 12654841 | 4 | 20150108 | 20150715 | 0 | |
| 126548411 | 12654841 | 5 | 20150806 | 0 | ||
| 126548411 | 12654841 | 6 | 20150108 | 0 |