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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106338383 | 10633838 | 3 | F | 20160727 | 20141205 | 20160915 | PER | US-ASTELLAS-2014US014127 | ASTELLAS | 0.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106338383 | 10633838 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG, ONCE DAILY (40 MG X 4) BY MOUTH | 203415 | 160 | MG | CAPSULE | QD | ||||||
| 106338383 | 10633838 | 2 | SS | XGEVA | DENOSUMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 106338383 | 10633838 | 3 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 4 | C | POTASSIUM CITRATE. | POTASSIUM CITRATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 5 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 6 | C | OXYCODONE | OXYCODONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 7 | C | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 8 | C | AVAPRO | IRBESARTAN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 9 | C | CLONIDINE. | CLONIDINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 10 | C | POTASSIUM | POTASSIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 11 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 12 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 13 | C | KETOCONAZOLE. | KETOCONAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | CREAM | ||||||||
| 106338383 | 10633838 | 14 | C | SENNA /00142201/ | SENNA LEAF | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 15 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106338383 | 10633838 | 16 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106338383 | 10633838 | 1 | Prostate cancer |
| 106338383 | 10633838 | 2 | Product used for unknown indication |
| 106338383 | 10633838 | 3 | Product used for unknown indication |
| 106338383 | 10633838 | 4 | Product used for unknown indication |
| 106338383 | 10633838 | 5 | Product used for unknown indication |
| 106338383 | 10633838 | 6 | Product used for unknown indication |
| 106338383 | 10633838 | 7 | Product used for unknown indication |
| 106338383 | 10633838 | 8 | Product used for unknown indication |
| 106338383 | 10633838 | 9 | Product used for unknown indication |
| 106338383 | 10633838 | 10 | Product used for unknown indication |
| 106338383 | 10633838 | 11 | Product used for unknown indication |
| 106338383 | 10633838 | 12 | Product used for unknown indication |
| 106338383 | 10633838 | 13 | Product used for unknown indication |
| 106338383 | 10633838 | 14 | Product used for unknown indication |
| 106338383 | 10633838 | 15 | Product used for unknown indication |
| 106338383 | 10633838 | 16 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106338383 | 10633838 | Arthritis | |
| 106338383 | 10633838 | Asthenia | |
| 106338383 | 10633838 | Cough | |
| 106338383 | 10633838 | Gait disturbance | |
| 106338383 | 10633838 | Headache | |
| 106338383 | 10633838 | Hot flush | |
| 106338383 | 10633838 | Nasopharyngitis | |
| 106338383 | 10633838 | Pain in extremity | |
| 106338383 | 10633838 | Prostatic specific antigen increased | |
| 106338383 | 10633838 | Rhinorrhoea | |
| 106338383 | 10633838 | Sneezing |
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 |
|---|---|---|---|---|---|---|
| 106338383 | 10633838 | 1 | 20130821 | 0 | ||
| 106338383 | 10633838 | 2 | 20151026 | 0 | ||
| 106338383 | 10633838 | 3 | 20151026 | 0 |