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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115033435 | 11503343 | 5 | F | 20150603 | 20160708 | 20150914 | 20160715 | EXP | US-ASTELLAS-2015US024268 | ASTELLAS | 66.95 | YR | M | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115033435 | 11503343 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 160 | MG | CAPSULE | QD | ||||||
| 115033435 | 11503343 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 80 | MG | CAPSULE | |||||||
| 115033435 | 11503343 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 120 | MG | CAPSULE | |||||||
| 115033435 | 11503343 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 160 | MG | CAPSULE | |||||||
| 115033435 | 11503343 | 5 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 80 | MG | CAPSULE | |||||||
| 115033435 | 11503343 | 6 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 120 | MG | CAPSULE | |||||||
| 115033435 | 11503343 | 7 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 160 | MG | CAPSULE | QD | ||||||
| 115033435 | 11503343 | 8 | SS | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | Y | 0 | FORMULATION UNKNOWN | ||||||||
| 115033435 | 11503343 | 9 | SS | LIBRAX | CHLORDIAZEPOXIDE HYDROCHLORIDECLIDINIUM BROMIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | U | 0 | FORMULATION UNKNOWN | |||||||
| 115033435 | 11503343 | 10 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033435 | 11503343 | 11 | C | OXYBUTYNIN | OXYBUTYNIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033435 | 11503343 | 12 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033435 | 11503343 | 13 | C | AMITIZA | LUBIPROSTONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033435 | 11503343 | 14 | C | DETROL | TOLTERODINE TARTRATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115033435 | 11503343 | 1 | Prostate cancer |
| 115033435 | 11503343 | 8 | Product used for unknown indication |
| 115033435 | 11503343 | 9 | Product used for unknown indication |
| 115033435 | 11503343 | 10 | Product used for unknown indication |
| 115033435 | 11503343 | 11 | Product used for unknown indication |
| 115033435 | 11503343 | 12 | Product used for unknown indication |
| 115033435 | 11503343 | 13 | Product used for unknown indication |
| 115033435 | 11503343 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115033435 | 11503343 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115033435 | 11503343 | Abdominal discomfort | |
| 115033435 | 11503343 | Abdominal pain upper | |
| 115033435 | 11503343 | Anxiety | |
| 115033435 | 11503343 | Asthenia | |
| 115033435 | 11503343 | Blood urine present | |
| 115033435 | 11503343 | Cataract | |
| 115033435 | 11503343 | Constipation | |
| 115033435 | 11503343 | Decreased appetite | |
| 115033435 | 11503343 | Dehydration | |
| 115033435 | 11503343 | Drug effect decreased | |
| 115033435 | 11503343 | Fluid intake reduced | |
| 115033435 | 11503343 | Gastric disorder | |
| 115033435 | 11503343 | Hyperchlorhydria | |
| 115033435 | 11503343 | Hypertension | |
| 115033435 | 11503343 | Hypophagia | |
| 115033435 | 11503343 | Malaise | |
| 115033435 | 11503343 | Nausea | |
| 115033435 | 11503343 | Urinary retention | |
| 115033435 | 11503343 | Urinary tract infection enterococcal | |
| 115033435 | 11503343 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 115033435 | 11503343 | 1 | 20150417 | 0 | ||
| 115033435 | 11503343 | 2 | 20150423 | 0 | ||
| 115033435 | 11503343 | 3 | 20150430 | 0 | ||
| 115033435 | 11503343 | 4 | 20150507 | 20150730 | 0 | |
| 115033435 | 11503343 | 5 | 20150820 | 0 | ||
| 115033435 | 11503343 | 6 | 201508 | 0 | ||
| 115033435 | 11503343 | 7 | 2015 | 0 |