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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103450339 | 10345033 | 9 | F | 20140619 | 20160623 | 20140728 | 20160630 | EXP | JP-ASTELLAS-2014JP015017 | ASTELLAS | KAKUTA T, MIURA N, FUKUMOTO T, YANAGIHARA Y, ASAI S, NODA T, ET AL.. ENZALUTAMIDE TREATMENT FOR CASTRATION-RESISTANT PROSTATE CANCER. EHIME MEDICAL JOURNAL. 2016;35 (1):24-7 | 80.79 | YR | M | Y | 52.00000 | KG | 20160630 | COUNTRY NOT SPECIFIED | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 103450339 | 10345033 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 4320 | MG | N | 203415 | 160 | MG | CAPSULE | QD | ||||
| 103450339 | 10345033 | 2 | SS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 4320 | MG | N | 203415 | 80 | MG | CAPSULE | QD | ||||
| 103450339 | 10345033 | 3 | SS | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | Oral | 0 | 3 | MG | CAPSULE | QD | |||||||
| 103450339 | 10345033 | 4 | C | PRIMPERAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Oral | U | 0 | 5 | MG | TABLET | TID | ||||||
| 103450339 | 10345033 | 5 | C | DECADRON | DEXAMETHASONE | 1 | Oral | U | 0 | 1 | MG | TABLET | QD | ||||||
| 103450339 | 10345033 | 6 | C | MESTINON | PYRIDOSTIGMINE BROMIDE | 1 | Oral | U | 0 | 60 | MG | TABLET | TID | ||||||
| 103450339 | 10345033 | 7 | C | ALFAROL | ALFACALCIDOL | 1 | Oral | 0.25 ?G, TWICE DAILY | U | 0 | .25 | UG | CAPSULE | BID | |||||
| 103450339 | 10345033 | 8 | C | TAKEPRON | LANSOPRAZOLE | 1 | Oral | U | 0 | 15 | MG | ORODISPERSIBLE TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 103450339 | 10345033 | 1 | Hormone-refractory prostate cancer |
| 103450339 | 10345033 | 3 | Myasthenia gravis |
| 103450339 | 10345033 | 4 | Nausea |
| 103450339 | 10345033 | 5 | Hormone-refractory prostate cancer |
| 103450339 | 10345033 | 6 | Myasthenia gravis |
| 103450339 | 10345033 | 7 | Osteoporosis |
| 103450339 | 10345033 | 8 | Gastrooesophageal reflux disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 103450339 | 10345033 | OT |
| 103450339 | 10345033 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 103450339 | 10345033 | Anaemia | |
| 103450339 | 10345033 | Decreased appetite | |
| 103450339 | 10345033 | Neutropenia |
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 |
|---|---|---|---|---|---|---|
| 103450339 | 10345033 | 1 | 20140619 | 20140715 | 0 | |
| 103450339 | 10345033 | 2 | 20140724 | 0 | ||
| 103450339 | 10345033 | 4 | 20140725 | 0 | ||
| 103450339 | 10345033 | 5 | 20140618 | 0 |