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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125817383 | 12581738 | 3 | F | 20160804 | 20160722 | 20160814 | EXP | US-JNJFOC-20160707313 | JOHNSON AND JOHNSON | 0.00 | E | M | Y | 0.00000 | 20160814 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125817383 | 12581738 | 1 | PS | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | AT BEDTIME | U | U | 999999 | UNSPECIFIED | |||||||
| 125817383 | 12581738 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 0 | 160 | MG | CAPSULE | QD | |||||||
| 125817383 | 12581738 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 0 | 160 | MG | CAPSULE | QD | |||||||
| 125817383 | 12581738 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 0 | 160 | MG | CAPSULE | QD | |||||||
| 125817383 | 12581738 | 5 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 0 | 160 | MG | CAPSULE | QD | |||||||
| 125817383 | 12581738 | 6 | C | ALEVE | NAPROXEN SODIUM | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125817383 | 12581738 | 1 | Insomnia |
| 125817383 | 12581738 | 2 | Colon cancer |
| 125817383 | 12581738 | 3 | Colon cancer |
| 125817383 | 12581738 | 4 | Prostate cancer |
| 125817383 | 12581738 | 5 | Prostate cancer |
| 125817383 | 12581738 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125817383 | 12581738 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125817383 | 12581738 | Abdominal discomfort | |
| 125817383 | 12581738 | Agitation | |
| 125817383 | 12581738 | Drug dose omission | |
| 125817383 | 12581738 | Feeling abnormal | |
| 125817383 | 12581738 | Muscle twitching | |
| 125817383 | 12581738 | Nausea | |
| 125817383 | 12581738 | Neuropathy peripheral | |
| 125817383 | 12581738 | Off label use | |
| 125817383 | 12581738 | Product use issue | |
| 125817383 | 12581738 | Urinary tract disorder | |
| 125817383 | 12581738 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125817383 | 12581738 | 2 | 20160217 | 2016 | 0 | |
| 125817383 | 12581738 | 3 | 20160318 | 0 | ||
| 125817383 | 12581738 | 4 | 20160318 | 0 | ||
| 125817383 | 12581738 | 5 | 20160217 | 2016 | 0 |