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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351144 | 12635114 | 4 | F | 2016 | 20160920 | 20160809 | 20160929 | EXP | JP-FERRINGPH-2016FE03693 | FERRING | 0.00 | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126351144 | 12635114 | 1 | PS | GONAX | DEGARELIX | 1 | Subcutaneous | 240 MG, ONCE/SINGLE | D | 22201 | 240 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||
| 126351144 | 12635114 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG, 1 TIME DAILY | 6720 | MG | D | 0 | 160 | MG | CAPSULE | QD | |||
| 126351144 | 12635114 | 3 | SS | SAWACILLIN | AMOXICILLIN | 1 | Oral | 1 DF, 3 TIMES DAILY | 42 | DF | D | 0 | 1 | DF | CAPSULE | TID | |||
| 126351144 | 12635114 | 4 | SS | CRAVIT | LEVOFLOXACIN | 1 | Oral | 1 DF, 1 TIME DAILY | 8 | DF | D | 0 | 1 | DF | TABLET | QD | |||
| 126351144 | 12635114 | 5 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 126351144 | 12635114 | 6 | C | RANMARK | DENOSUMAB | 1 | UNK | 0 | INJECTION | ||||||||||
| 126351144 | 12635114 | 7 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | UNK | 0 | TABLET | |||||||||
| 126351144 | 12635114 | 8 | C | ADONA /00056903/ | CARBAZOCHROME SODIUM SULFONATE | 1 | UNK | 0 | TABLET | ||||||||||
| 126351144 | 12635114 | 9 | C | TRANSAMIN | TRANEXAMIC ACID | 1 | UNK | 0 | CAPSULE | ||||||||||
| 126351144 | 12635114 | 10 | C | LOXONIN | LOXOPROFEN SODIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 126351144 | 12635114 | 11 | C | MUCOSTA | REBAMIPIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 126351144 | 12635114 | 12 | C | URSO | URSODIOL | 1 | 0.5 DF, 3 TIMES DAILY | 0 | .5 | DF | TABLET | TID | |||||||
| 126351144 | 12635114 | 13 | C | ZYTIGA | ABIRATERONE ACETATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126351144 | 12635114 | 1 | Prostate cancer |
| 126351144 | 12635114 | 2 | Hormone-refractory prostate cancer |
| 126351144 | 12635114 | 3 | Cystitis |
| 126351144 | 12635114 | 4 | Cystitis |
| 126351144 | 12635114 | 12 | Hepatic function abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126351144 | 12635114 | HO |
| 126351144 | 12635114 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126351144 | 12635114 | Cystitis haemorrhagic | |
| 126351144 | 12635114 | Decreased appetite | |
| 126351144 | 12635114 | Dehydration | |
| 126351144 | 12635114 | Drug-induced liver injury | |
| 126351144 | 12635114 | Gastroenteritis eosinophilic | |
| 126351144 | 12635114 | Hepatitis acute | |
| 126351144 | 12635114 | 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 |
|---|---|---|---|---|---|---|
| 126351144 | 12635114 | 1 | 20160609 | 20160609 | 0 | |
| 126351144 | 12635114 | 2 | 20160512 | 20160627 | 0 | |
| 126351144 | 12635114 | 3 | 20160609 | 20160623 | 0 | |
| 126351144 | 12635114 | 4 | 20160526 | 20160603 | 0 | |
| 126351144 | 12635114 | 5 | 20150903 | 20160627 | 0 | |
| 126351144 | 12635114 | 6 | 20130418 | 20160609 | 0 | |
| 126351144 | 12635114 | 7 | 20151105 | 20160627 | 0 | |
| 126351144 | 12635114 | 8 | 20160616 | 20160623 | 0 | |
| 126351144 | 12635114 | 9 | 20160616 | 20160623 | 0 | |
| 126351144 | 12635114 | 10 | 20150903 | 20160623 | 0 | |
| 126351144 | 12635114 | 11 | 20150903 | 20160623 | 0 | |
| 126351144 | 12635114 | 12 | 20160623 | 20160707 | 0 |