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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127493001 | 12749300 | 1 | I | 201603 | 20160411 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US014024 | ASTELLAS | 84.58 | YR | M | Y | 0.00000 | 20160915 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127493001 | 12749300 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 203415 | 160 | MG | CAPSULE | QD | |||||||
| 127493001 | 12749300 | 2 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | 5 | MG | FORMULATION UNKNOWN | |||||||
| 127493001 | 12749300 | 3 | C | AZOR /00595201/ | ALPRAZOLAM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 4 | C | Atorvastatin | ATORVASTATIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 5 | C | MEGACE | MEGESTROL ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 6 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 7 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 8 | C | ALOE VERA | ALOE VERA LEAF | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | CAPSULE | ||||||||
| 127493001 | 12749300 | 9 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 10 | C | PROBIOTIC /06395501/ | BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 11 | C | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 12 | C | ZOCOR | SIMVASTATIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 13 | C | MEGESTROL | MEGESTROL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127493001 | 12749300 | 14 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127493001 | 12749300 | 1 | Prostate cancer |
| 127493001 | 12749300 | 2 | Depression |
| 127493001 | 12749300 | 3 | Product used for unknown indication |
| 127493001 | 12749300 | 4 | Product used for unknown indication |
| 127493001 | 12749300 | 5 | Product used for unknown indication |
| 127493001 | 12749300 | 6 | Product used for unknown indication |
| 127493001 | 12749300 | 7 | Product used for unknown indication |
| 127493001 | 12749300 | 8 | Product used for unknown indication |
| 127493001 | 12749300 | 9 | Product used for unknown indication |
| 127493001 | 12749300 | 10 | Product used for unknown indication |
| 127493001 | 12749300 | 11 | Product used for unknown indication |
| 127493001 | 12749300 | 12 | Product used for unknown indication |
| 127493001 | 12749300 | 13 | Product used for unknown indication |
| 127493001 | 12749300 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127493001 | 12749300 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127493001 | 12749300 | Asthenia | |
| 127493001 | 12749300 | Back pain | |
| 127493001 | 12749300 | Cough | |
| 127493001 | 12749300 | Decreased appetite | |
| 127493001 | 12749300 | Diarrhoea | |
| 127493001 | 12749300 | Drug intolerance | |
| 127493001 | 12749300 | Fatigue | |
| 127493001 | 12749300 | Feeling abnormal | |
| 127493001 | 12749300 | Influenza like illness | |
| 127493001 | 12749300 | Malaise | |
| 127493001 | 12749300 | Nasal congestion | |
| 127493001 | 12749300 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 127493001 | 12749300 | 1 | 20160321 | 0 |