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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115024782 | 11502478 | 2 | F | 2016 | 20160906 | 20150914 | 20160915 | PER | US-ASTELLAS-2015US021419 | ASTELLAS | 68.46 | YR | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115024782 | 11502478 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1484205PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 115024782 | 11502478 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 120 | MG | CAPSULE | QD | ||||||
| 115024782 | 11502478 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 203415 | 160 | MG | CAPSULE | QD | |||||||
| 115024782 | 11502478 | 4 | SS | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115024782 | 11502478 | 5 | SS | MS CONTIN | MORPHINE SULFATE | 1 | Oral | 0 | 30 | MG | TABLET | BID | |||||||
| 115024782 | 11502478 | 6 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 25 MG, ONCE DAILY (0.5 OF A 50 MG TABLET) | U | 1543979PC | 0 | 25 | MG | TABLET | QD | ||||
| 115024782 | 11502478 | 7 | C | LOTREL | AMLODIPINE BESYLATEBENAZEPRIL HYDROCHLORIDE | 1 | Unknown | 10/20 MG, ONCE DAILY | U | 0 | FORMULATION UNKNOWN | QD | |||||||
| 115024782 | 11502478 | 8 | C | PROSCAR | FINASTERIDE | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | |||||||
| 115024782 | 11502478 | 9 | C | ACIPHEX | RABEPRAZOLE SODIUM | 1 | Unknown | U | 0 | 20 | MG | FORMULATION UNKNOWN | |||||||
| 115024782 | 11502478 | 10 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | U | 0 | 81 | MG | FORMULATION UNKNOWN | |||||||
| 115024782 | 11502478 | 11 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115024782 | 11502478 | 12 | C | STOOL SOFTENER | DOCUSATE CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115024782 | 11502478 | 13 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115024782 | 11502478 | 1 | Prostate cancer |
| 115024782 | 11502478 | 2 | Prostatic specific antigen |
| 115024782 | 11502478 | 4 | Pain |
| 115024782 | 11502478 | 5 | Pain |
| 115024782 | 11502478 | 6 | Product used for unknown indication |
| 115024782 | 11502478 | 7 | Blood pressure abnormal |
| 115024782 | 11502478 | 8 | Prostatic disorder |
| 115024782 | 11502478 | 9 | Abdominal discomfort |
| 115024782 | 11502478 | 10 | Product used for unknown indication |
| 115024782 | 11502478 | 11 | Product used for unknown indication |
| 115024782 | 11502478 | 12 | Product used for unknown indication |
| 115024782 | 11502478 | 13 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115024782 | 11502478 | Arthralgia | |
| 115024782 | 11502478 | Breast enlargement | |
| 115024782 | 11502478 | Breast tenderness | |
| 115024782 | 11502478 | Decreased appetite | |
| 115024782 | 11502478 | Flatulence | |
| 115024782 | 11502478 | Hypersensitivity | |
| 115024782 | 11502478 | Hypersomnia | |
| 115024782 | 11502478 | Increased bronchial secretion | |
| 115024782 | 11502478 | Increased upper airway secretion | |
| 115024782 | 11502478 | Musculoskeletal chest pain | |
| 115024782 | 11502478 | Pain | |
| 115024782 | 11502478 | Prostatic specific antigen increased |
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 |
|---|---|---|---|---|---|---|
| 115024782 | 11502478 | 1 | 20150416 | 0 |