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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126461541 | 12646154 | 1 | I | 2015 | 20151014 | 20160811 | 20160811 | PER | US-ENDO PHARMACEUTICALS INC.-2015-003495 | ENDO | 80.73 | YR | M | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126461541 | 12646154 | 1 | PS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | UNKNOWN | 40256 | UNKNOWN | |||||||||
| 126461541 | 12646154 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 0 | 160 | MG | CAPSULE | QD | |||||||
| 126461541 | 12646154 | 3 | C | FOSAMAX | ALENDRONATE SODIUM | 1 | 0 | ||||||||||||
| 126461541 | 12646154 | 4 | C | ATENOLOL TABLETS | ATENOLOL | 1 | 73542 | ||||||||||||
| 126461541 | 12646154 | 5 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 126461541 | 12646154 | 6 | C | TRAZODONE HYDROCHLORIDE TABLETS | TRAZODONE HYDROCHLORIDE | 1 | 72192 | TABLETS | |||||||||||
| 126461541 | 12646154 | 7 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 126461541 | 12646154 | 8 | C | PEPCID | FAMOTIDINE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126461541 | 12646154 | 1 | Product used for unknown indication |
| 126461541 | 12646154 | 2 | Prostate cancer |
| 126461541 | 12646154 | 3 | Product used for unknown indication |
| 126461541 | 12646154 | 4 | Product used for unknown indication |
| 126461541 | 12646154 | 5 | Product used for unknown indication |
| 126461541 | 12646154 | 6 | Product used for unknown indication |
| 126461541 | 12646154 | 7 | Product used for unknown indication |
| 126461541 | 12646154 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126461541 | 12646154 | Drug ineffective | |
| 126461541 | 12646154 | Fatigue |
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 |
|---|---|---|---|---|---|---|
| 126461541 | 12646154 | 2 | 20150214 | 0 |