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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125496736 | 12549673 | 6 | F | 20160512 | 20160920 | 20160712 | 20160923 | EXP | JP-ASTELLAS-2016JP011218AA | ASTELLAS | 66.37 | YR | M | Y | 63.00000 | KG | 20160923 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125496736 | 12549673 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 6880 | MG | Y | 203415 | 160 | MG | CAPSULE | QD | ||||
| 125496736 | 12549673 | 2 | SS | Sawacillin | AMOXICILLIN | 1 | Oral | 45 | DF | Y | 0 | 1 | DF | CAPSULE | TID | ||||
| 125496736 | 12549673 | 3 | SS | Gonax | DEGARELIX | 1 | Subcutaneous | 240 | MG | D | 0 | 240 | MG | INJECTION | |||||
| 125496736 | 12549673 | 4 | SS | CRAVIT | LEVOFLOXACIN | 1 | Oral | 9 | DF | D | 0 | 1 | DF | TABLET | QD | ||||
| 125496736 | 12549673 | 5 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | 1470 | MG | D | U | 0 | 5 | MG | TABLET | QD | |||
| 125496736 | 12549673 | 6 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | UNK UNK, UNKNOWN FREQ. | 1470 | MG | D | U | 0 | TABLET | |||||
| 125496736 | 12549673 | 7 | C | RANMARK | DENOSUMAB | 1 | Subcutaneous | 137880 | MG | D | U | 0 | 120 | MG | INJECTION | QD | |||
| 125496736 | 12549673 | 8 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | 464 | DF | D | U | 0 | 2 | DF | TABLET | QD | |||
| 125496736 | 12549673 | 9 | C | ADONA /00056903/ | CARBAZOCHROME SODIUM SULFONATE | 1 | Oral | 24 | DF | D | U | 0 | 1 | DF | TABLET | TID | |||
| 125496736 | 12549673 | 10 | C | TRANSAMIN | TRANEXAMIC ACID | 1 | Unknown | 24 | DF | D | U | 0 | 1 | DF | CAPSULE | TID | |||
| 125496736 | 12549673 | 11 | C | LOXONIN | LOXOPROFEN SODIUM | 1 | Unknown | 885 | DF | D | U | 0 | 1 | DF | TABLET | TID | |||
| 125496736 | 12549673 | 12 | C | MUCOSTA | REBAMIPIDE | 1 | Unknown | 885 | DF | D | U | 0 | 1 | DF | TABLET | TID | |||
| 125496736 | 12549673 | 13 | C | URSO | URSODIOL | 1 | Oral | 0.5 DF, THRICE DAILY | D | U | 0 | .5 | DF | TABLET | TID | ||||
| 125496736 | 12549673 | 14 | C | URSO | URSODIOL | 1 | U | 0 | TABLET | ||||||||||
| 125496736 | 12549673 | 15 | C | ZYTIGA | ABIRATERONE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125496736 | 12549673 | 1 | Hormone-refractory prostate cancer |
| 125496736 | 12549673 | 2 | Cystitis |
| 125496736 | 12549673 | 3 | Prostate cancer |
| 125496736 | 12549673 | 4 | Cystitis |
| 125496736 | 12549673 | 5 | Decreased appetite |
| 125496736 | 12549673 | 6 | Urticaria |
| 125496736 | 12549673 | 7 | Prostate cancer |
| 125496736 | 12549673 | 8 | Product used for unknown indication |
| 125496736 | 12549673 | 9 | Cystitis haemorrhagic |
| 125496736 | 12549673 | 10 | Cystitis haemorrhagic |
| 125496736 | 12549673 | 11 | Dysuria |
| 125496736 | 12549673 | 12 | Chronic gastritis |
| 125496736 | 12549673 | 13 | Hepatic function abnormal |
| 125496736 | 12549673 | 14 | Hepatitis acute |
| 125496736 | 12549673 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125496736 | 12549673 | DE |
| 125496736 | 12549673 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125496736 | 12549673 | Cystitis haemorrhagic | |
| 125496736 | 12549673 | Decreased appetite | |
| 125496736 | 12549673 | Dehydration | |
| 125496736 | 12549673 | Gastroenteritis eosinophilic | |
| 125496736 | 12549673 | Hepatitis acute | |
| 125496736 | 12549673 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 125496736 | 12549673 | 1 | 20160512 | 20160627 | 0 | |
| 125496736 | 12549673 | 2 | 20160609 | 20160623 | 0 | |
| 125496736 | 12549673 | 3 | 20160609 | 20160609 | 0 | |
| 125496736 | 12549673 | 4 | 20160526 | 20160603 | 0 | |
| 125496736 | 12549673 | 5 | 20150903 | 20160622 | 0 | |
| 125496736 | 12549673 | 6 | 20160623 | 20160627 | 0 | |
| 125496736 | 12549673 | 7 | 20130418 | 20160609 | 0 | |
| 125496736 | 12549673 | 8 | 20151105 | 20160627 | 0 | |
| 125496736 | 12549673 | 9 | 20160616 | 20160623 | 0 | |
| 125496736 | 12549673 | 10 | 20160616 | 20160623 | 0 | |
| 125496736 | 12549673 | 11 | 20150903 | 20160623 | 0 | |
| 125496736 | 12549673 | 12 | 20150903 | 20160623 | 0 | |
| 125496736 | 12549673 | 13 | 20160623 | 20160707 | 0 |