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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104357297 | 10435729 | 7 | F | 20140703 | 20160629 | 20140908 | 20160706 | EXP | JP-ASTELLAS-2014JP016111 | ASTELLAS | 77.13 | YR | M | Y | 58.00000 | KG | 20160706 | CN | JP | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104357297 | 10435729 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 2560 | MG | Y | N | 203415 | 160 | MG | CAPSULE | QD | |||
| 104357297 | 10435729 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 2560 | MG | N | 203415 | 80 | MG | CAPSULE | QD | ||||
| 104357297 | 10435729 | 3 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Unknown | 162 | MG | Y | 0 | 3 | MG | INJECTION | |||||
| 104357297 | 10435729 | 4 | SS | RANMARK | DENOSUMAB | 1 | Subcutaneous | 0 | 120 | MG | INJECTION | ||||||||
| 104357297 | 10435729 | 5 | C | HARNAL | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.2 MG, ONCE DAILY | U | 0 | .2 | MG | ORODISPERSIBLE TABLET | QD | |||||
| 104357297 | 10435729 | 6 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | U | 0 | 20 | MG | CAPSULE | QD | ||||||
| 104357297 | 10435729 | 7 | C | DECADRON | DEXAMETHASONE | 1 | Oral | U | 0 | 1 | MG | TABLET | QD | ||||||
| 104357297 | 10435729 | 8 | C | DECADRON | DEXAMETHASONE | 1 | U | 0 | TABLET | ||||||||||
| 104357297 | 10435729 | 9 | C | ZYLORIC | ALLOPURINOL | 1 | Oral | U | 0 | 100 | MG | TABLET | QD | ||||||
| 104357297 | 10435729 | 10 | C | MEDICON /00048102/ | DEXTROMETHORPHAN HYDROBROMIDE | 1 | Oral | 9000 | MG | U | 0 | 30 | MG | TABLET | TID | ||||
| 104357297 | 10435729 | 11 | C | MICOMBI COMBINATION | HYDROCHLOROTHIAZIDETELMISARTAN | 1 | Oral | UNK, ONCE DAILY | U | 0 | TABLET | QD | |||||||
| 104357297 | 10435729 | 12 | C | ADALAT CC | NIFEDIPINE | 1 | Oral | U | 0 | 20 | MG | MODIFIED-RELEASE TABLET | BID | ||||||
| 104357297 | 10435729 | 13 | C | ZOLADEX | GOSERELIN ACETATE | 1 | Subcutaneous | 10.8 MG, EVERY 12 WEEKS | U | 0 | 10.8 | MG | INJECTION | ||||||
| 104357297 | 10435729 | 14 | C | CALCIUM COMPOUNDS | 2 | Oral | UNK UNK, UNKNOWN FREQ. | U | 0 | PER ORAL NOS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104357297 | 10435729 | 1 | Hormone-refractory prostate cancer |
| 104357297 | 10435729 | 3 | Metastases to bone |
| 104357297 | 10435729 | 4 | Metastases to bone |
| 104357297 | 10435729 | 5 | Dysuria |
| 104357297 | 10435729 | 6 | Hyperchlorhydria |
| 104357297 | 10435729 | 7 | Hormone-refractory prostate cancer |
| 104357297 | 10435729 | 8 | Metastases to bone |
| 104357297 | 10435729 | 9 | Hyperuricaemia |
| 104357297 | 10435729 | 10 | Interstitial lung disease |
| 104357297 | 10435729 | 11 | Hypertension |
| 104357297 | 10435729 | 12 | Hypertension |
| 104357297 | 10435729 | 13 | Product used for unknown indication |
| 104357297 | 10435729 | 14 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104357297 | 10435729 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104357297 | 10435729 | Hypocalcaemia | |
| 104357297 | 10435729 | Malaise | |
| 104357297 | 10435729 | Renal impairment |
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 |
|---|---|---|---|---|---|---|
| 104357297 | 10435729 | 1 | 20140618 | 20140709 | 0 | |
| 104357297 | 10435729 | 2 | 20140828 | 0 | ||
| 104357297 | 10435729 | 3 | 20100513 | 20140618 | 0 | |
| 104357297 | 10435729 | 4 | 20140730 | 0 | ||
| 104357297 | 10435729 | 5 | 20140512 | 0 | ||
| 104357297 | 10435729 | 6 | 20130207 | 0 | ||
| 104357297 | 10435729 | 7 | 20130306 | 0 | ||
| 104357297 | 10435729 | 9 | 20130321 | 0 | ||
| 104357297 | 10435729 | 10 | 20140326 | 20140709 | 0 | |
| 104357297 | 10435729 | 13 | 20100110 | 0 | ||
| 104357297 | 10435729 | 14 | 20140730 | 0 |