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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892461 | 12689246 | 1 | I | 20160212 | 20160318 | 20160826 | 20160826 | EXP | FI-ASTELLAS-2016US010759AA | ASTELLAS | 75.63 | YR | M | Y | 0.00000 | 20160826 | CN | FI | FI |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892461 | 12689246 | 1 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 126892461 | 12689246 | 2 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 90400 | MG | Y | 203415 | 160 | MG | CAPSULE | QD | ||||
| 126892461 | 12689246 | 3 | C | MAREVAN | WARFARIN SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 4 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 5 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 6 | C | LECROLYN | 2 | Unknown | UNK UNK, UNKNOWN FREQ. (DROP) | U | 0 | FORMULATION UNKNOWN | |||||||||
| 126892461 | 12689246 | 7 | C | OFTAGEL | CARBOMER | 1 | Unknown | UNK UNK, UNKNOWN FREQ. (DROP) | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 8 | C | DINIT | ISOSORBIDE DINITRATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 9 | C | AMLODIPIN /00972401/ | AMLODIPINE BESYLATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 10 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 11 | C | KALEORID | POTASSIUM CHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 12 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 13 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 14 | C | PANACOD | ACETAMINOPHENCODEINE PHOSPHATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 15 | C | MONTELUKAST | MONTELUKAST SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 16 | C | SOMAC | PANTOPRAZOLE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126892461 | 12689246 | 17 | C | HEINIX | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126892461 | 12689246 | 1 | Prostate cancer |
| 126892461 | 12689246 | 2 | Prostate cancer |
| 126892461 | 12689246 | 3 | Product used for unknown indication |
| 126892461 | 12689246 | 4 | Product used for unknown indication |
| 126892461 | 12689246 | 5 | Product used for unknown indication |
| 126892461 | 12689246 | 6 | Product used for unknown indication |
| 126892461 | 12689246 | 7 | Product used for unknown indication |
| 126892461 | 12689246 | 8 | Product used for unknown indication |
| 126892461 | 12689246 | 9 | Product used for unknown indication |
| 126892461 | 12689246 | 10 | Product used for unknown indication |
| 126892461 | 12689246 | 11 | Product used for unknown indication |
| 126892461 | 12689246 | 12 | Product used for unknown indication |
| 126892461 | 12689246 | 13 | Product used for unknown indication |
| 126892461 | 12689246 | 14 | Product used for unknown indication |
| 126892461 | 12689246 | 15 | Product used for unknown indication |
| 126892461 | 12689246 | 16 | Product used for unknown indication |
| 126892461 | 12689246 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126892461 | 12689246 | HO |
| 126892461 | 12689246 | LT |
| 126892461 | 12689246 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126892461 | 12689246 | Fall | |
| 126892461 | 12689246 | Myocardial infarction | |
| 126892461 | 12689246 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 126892461 | 12689246 | 1 | 20111216 | 20131212 | 0 | |
| 126892461 | 12689246 | 2 | 20140813 | 20160228 | 0 | |
| 126892461 | 12689246 | 3 | 201109 | 0 | ||
| 126892461 | 12689246 | 4 | 1978 | 0 | ||
| 126892461 | 12689246 | 5 | 1985 | 0 | ||
| 126892461 | 12689246 | 6 | 2009 | 0 | ||
| 126892461 | 12689246 | 7 | 2009 | 0 | ||
| 126892461 | 12689246 | 8 | 1985 | 0 | ||
| 126892461 | 12689246 | 9 | 1995 | 0 | ||
| 126892461 | 12689246 | 10 | 201111 | 0 | ||
| 126892461 | 12689246 | 11 | 20111216 | 0 | ||
| 126892461 | 12689246 | 12 | 201204 | 0 | ||
| 126892461 | 12689246 | 13 | 1995 | 0 | ||
| 126892461 | 12689246 | 14 | 201204 | 0 | ||
| 126892461 | 12689246 | 15 | 20121001 | 0 | ||
| 126892461 | 12689246 | 16 | 2008 | 0 | ||
| 126892461 | 12689246 | 17 | 20130812 | 0 |