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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1150375710 | 11503757 | 10 | F | 2015 | 20160718 | 20150914 | 20160725 | EXP | US-ASTELLAS-2015US027840 | ASTELLAS | 79.57 | YR | M | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1150375710 | 11503757 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1507016PCB | 203415 | 160 | MG | CAPSULE | QD | |||||
| 1150375710 | 11503757 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 80 | MG | CAPSULE | QD | ||||||
| 1150375710 | 11503757 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1507016PCB | 203415 | 120 | MG | CAPSULE | QD | |||||
| 1150375710 | 11503757 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | U | 1507032PC | 203415 | 160 | MG | CAPSULE | ||||||
| 1150375710 | 11503757 | 5 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | U | 15016825PC,1521458PC,1526650PC | 203415 | 120 | MG | CAPSULE | QD | |||||
| 1150375710 | 11503757 | 6 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | U | 1539683PC | 203415 | 120 | MG | CAPSULE | BID | |||||
| 1150375710 | 11503757 | 7 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1543982PC/1507016PCB | 203415 | 120 | MG | CAPSULE | QD | |||||
| 1150375710 | 11503757 | 8 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1150375710 | 11503757 | 1 | Prostate cancer |
| 1150375710 | 11503757 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1150375710 | 11503757 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1150375710 | 11503757 | Abdominal discomfort | |
| 1150375710 | 11503757 | Amnesia | |
| 1150375710 | 11503757 | Anxiety | |
| 1150375710 | 11503757 | Asthenia | |
| 1150375710 | 11503757 | Back pain | |
| 1150375710 | 11503757 | Bladder disorder | |
| 1150375710 | 11503757 | Blood pressure increased | |
| 1150375710 | 11503757 | Confusional state | |
| 1150375710 | 11503757 | Diarrhoea | |
| 1150375710 | 11503757 | Disorientation | |
| 1150375710 | 11503757 | Dizziness | |
| 1150375710 | 11503757 | Dry skin | |
| 1150375710 | 11503757 | Dyspnoea | |
| 1150375710 | 11503757 | Fatigue | |
| 1150375710 | 11503757 | Hair texture abnormal | |
| 1150375710 | 11503757 | Headache | |
| 1150375710 | 11503757 | Insomnia | |
| 1150375710 | 11503757 | Micturition disorder | |
| 1150375710 | 11503757 | Musculoskeletal stiffness | |
| 1150375710 | 11503757 | Nephrostomy | |
| 1150375710 | 11503757 | Overdose | |
| 1150375710 | 11503757 | Paranasal sinus discomfort | |
| 1150375710 | 11503757 | Rhinorrhoea | |
| 1150375710 | 11503757 | Sinus congestion | |
| 1150375710 | 11503757 | Sinus disorder | |
| 1150375710 | 11503757 | Sinusitis | |
| 1150375710 | 11503757 | Vertigo | |
| 1150375710 | 11503757 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 1150375710 | 11503757 | 1 | 20150815 | 0 | ||
| 1150375710 | 11503757 | 2 | 20150818 | 0 | ||
| 1150375710 | 11503757 | 3 | 20150825 | 0 |