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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117709269 | 11770926 | 9 | F | 20150417 | 20160808 | 20151123 | 20160816 | EXP | US-JNJFOC-20151021859 | JANSSEN | 66.83 | YR | E | M | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117709269 | 11770926 | 1 | PS | ULTRAM | TRAMADOL HYDROCHLORIDE | 1 | Oral | EVERY 6 HOURS | N | 20281 | 50 | MG | TABLETS | QID | |||||
| 117709269 | 11770926 | 2 | SS | LIBRAX | CHLORDIAZEPOXIDE HYDROCHLORIDECLIDINIUM BROMIDE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 117709269 | 11770926 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 0 | 120 | MG | CAPSULE | |||||||
| 117709269 | 11770926 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 0 | 120 | MG | CAPSULE | |||||||
| 117709269 | 11770926 | 5 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 0 | 80 | MG | CAPSULE | |||||||
| 117709269 | 11770926 | 6 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 0 | 160 | MG | CAPSULE | |||||||
| 117709269 | 11770926 | 7 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 0 | 80 | MG | CAPSULE | |||||||
| 117709269 | 11770926 | 8 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 0 | 160 | MG | CAPSULE | QD | ||||||
| 117709269 | 11770926 | 9 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 0 | 160 | MG | CAPSULE | QD | ||||||
| 117709269 | 11770926 | 10 | C | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | 0 | 45 | MG | INJECTION | ||||||||
| 117709269 | 11770926 | 11 | C | LOMOTIL | ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE | 1 | Unknown | 2.5-0.025MG | 0 | UNKNOWN | |||||||||
| 117709269 | 11770926 | 12 | C | DICLOFENAC SODIUM. | DICLOFENAC SODIUM | 1 | Unknown | 0 | 75 | MG | UNKNOWN | BID | |||||||
| 117709269 | 11770926 | 13 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0 | .5 | MG | UNKNOWN | ||||||||
| 117709269 | 11770926 | 14 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | Unknown | AT PM, STARTED AS PER CARDIOOGIST | 0 | 20 | MG | UNKNOWN | QD | ||||||
| 117709269 | 11770926 | 15 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | 20 | MG | CAPSULE | QID | |||||||
| 117709269 | 11770926 | 16 | C | OXYBUTYNIN HYDROCHLORIDE | OXYBUTYNIN CHLORIDE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 117709269 | 11770926 | 17 | C | FOSFOMYCIN TROMETAMOL | 2 | Unknown | 0 | UNSPECIFIED | |||||||||||
| 117709269 | 11770926 | 18 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 0 | 81 | MG | UNKNOWN | QD | |||||||
| 117709269 | 11770926 | 19 | C | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Unknown | IN AM, AS PER CARDIOLOGIST. | 0 | 40 | MG | UNKNOWN | QD | ||||||
| 117709269 | 11770926 | 20 | C | CALCIUM W/VITAMIN D NOS | CALCIUMVITAMIN D | 1 | Unknown | VIT D 800 IU | 0 | 600 | MG | UNKNOWN | BID | ||||||
| 117709269 | 11770926 | 21 | C | CENTRUM SILVER | MINERALSVITAMINS | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 117709269 | 11770926 | 22 | C | L THYROXINE | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | .75 | UG | TABLET | QD | |||||||
| 117709269 | 11770926 | 23 | C | PROCHLORPERAZINE. | PROCHLORPERAZINE | 1 | Unknown | 0 | 5 | MG | UNKNOWN | ||||||||
| 117709269 | 11770926 | 24 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 0 | 40 | MG | TABLET | QD | |||||||
| 117709269 | 11770926 | 25 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | IN AM | 0 | 25 | MG | UNKNOWN | QD | ||||||
| 117709269 | 11770926 | 26 | C | DENOSUMAB | DENOSUMAB | 1 | Unknown | 0 | INJECTION | ||||||||||
| 117709269 | 11770926 | 27 | C | AMITIZA | LUBIPROSTONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 117709269 | 11770926 | 28 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 117709269 | 11770926 | 29 | C | DETROL | TOLTERODINE TARTRATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117709269 | 11770926 | 1 | Pain |
| 117709269 | 11770926 | 2 | Product used for unknown indication |
| 117709269 | 11770926 | 3 | Prostate cancer |
| 117709269 | 11770926 | 4 | Prostate cancer |
| 117709269 | 11770926 | 5 | Prostate cancer |
| 117709269 | 11770926 | 6 | Prostate cancer |
| 117709269 | 11770926 | 7 | Prostate cancer |
| 117709269 | 11770926 | 8 | Prostate cancer |
| 117709269 | 11770926 | 9 | Prostate cancer |
| 117709269 | 11770926 | 10 | Neoplasm malignant |
| 117709269 | 11770926 | 11 | Diarrhoea |
| 117709269 | 11770926 | 12 | Arthritis |
| 117709269 | 11770926 | 13 | Anxiety |
| 117709269 | 11770926 | 14 | Product used for unknown indication |
| 117709269 | 11770926 | 15 | Gastrooesophageal reflux disease |
| 117709269 | 11770926 | 16 | Product used for unknown indication |
| 117709269 | 11770926 | 17 | Product used for unknown indication |
| 117709269 | 11770926 | 18 | Anticoagulant therapy |
| 117709269 | 11770926 | 19 | Hypertension |
| 117709269 | 11770926 | 20 | Nutritional supplementation |
| 117709269 | 11770926 | 21 | Vitamin supplementation |
| 117709269 | 11770926 | 22 | Thyroid disorder |
| 117709269 | 11770926 | 23 | Nausea |
| 117709269 | 11770926 | 24 | Blood cholesterol |
| 117709269 | 11770926 | 25 | Hyperaldosteronism |
| 117709269 | 11770926 | 26 | Product used for unknown indication |
| 117709269 | 11770926 | 27 | Product used for unknown indication |
| 117709269 | 11770926 | 28 | Product used for unknown indication |
| 117709269 | 11770926 | 29 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117709269 | 11770926 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117709269 | 11770926 | Abdominal pain upper | |
| 117709269 | 11770926 | Anxiety | |
| 117709269 | 11770926 | Asthenia | |
| 117709269 | 11770926 | Blood urine present | |
| 117709269 | 11770926 | Cataract operation | |
| 117709269 | 11770926 | Constipation | |
| 117709269 | 11770926 | Decreased appetite | |
| 117709269 | 11770926 | Dehydration | |
| 117709269 | 11770926 | Dysuria | |
| 117709269 | 11770926 | Fluid intake reduced | |
| 117709269 | 11770926 | Gastric disorder | |
| 117709269 | 11770926 | Hyperchlorhydria | |
| 117709269 | 11770926 | Hypophagia | |
| 117709269 | 11770926 | Malaise | |
| 117709269 | 11770926 | Nausea | |
| 117709269 | 11770926 | Urinary tract infection enterococcal | |
| 117709269 | 11770926 | 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 |
|---|---|---|---|---|---|---|
| 117709269 | 11770926 | 1 | 20150401 | 0 | ||
| 117709269 | 11770926 | 3 | 20150430 | 0 | ||
| 117709269 | 11770926 | 4 | 201508 | 0 | ||
| 117709269 | 11770926 | 5 | 20150423 | 0 | ||
| 117709269 | 11770926 | 6 | 20150507 | 20150730 | 0 | |
| 117709269 | 11770926 | 7 | 20150820 | 0 | ||
| 117709269 | 11770926 | 8 | 2015 | 0 | ||
| 117709269 | 11770926 | 9 | 20150417 | 0 | ||
| 117709269 | 11770926 | 14 | 20130806 | 0 | ||
| 117709269 | 11770926 | 18 | 20130729 | 0 |