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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127502401 | 12750240 | 1 | I | 201604 | 20160510 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US018599 | ASTELLAS | 88.26 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127502401 | 12750240 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 160 | MG | CAPSULE | QD | ||||||
| 127502401 | 12750240 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 203415 | 160 | MG | CAPSULE | QD | |||||||
| 127502401 | 12750240 | 3 | SS | PERCOCET /00446701/ | ACETAMINOPHENOXYCODONE HYDROCHLORIDEOXYCODONE TEREPHTHALATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | U | 0 | FORMULATION UNKNOWN | |||||||
| 127502401 | 12750240 | 4 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | U | 0 | 45 | MG | INJECTION | |||||||
| 127502401 | 12750240 | 5 | C | DOCUSATE SODIUM. | DOCUSATE SODIUM | 1 | Unknown | U | 0 | 100 | MG | CAPSULE | |||||||
| 127502401 | 12750240 | 6 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | U | 0 | 1000 | MG | TABLET | |||||||
| 127502401 | 12750240 | 7 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | U | 0 | 500 | MG | TABLET | |||||||
| 127502401 | 12750240 | 8 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 50 MG,ER UNKNOWN FREQ. | U | 0 | 50 | MG | TABLET | ||||||
| 127502401 | 12750240 | 9 | C | NYSTATIN. | NYSTATIN | 1 | Unknown | UNK 100000, UNKNOWN FREQ. | U | 0 | CREAM | ||||||||
| 127502401 | 12750240 | 10 | C | OXYCODONE W/APAP | ACETAMINOPHENOXYCODONE HYDROCHLORIDE | 1 | Unknown | 5-325 MG, UNKNOWN FREQ. | U | 0 | TABLET | ||||||||
| 127502401 | 12750240 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | U | 0 | 40 | MG | TABLET | |||||||
| 127502401 | 12750240 | 12 | C | AZITHROMYCIN ANHYDROUS. | AZITHROMYCIN ANHYDROUS | 1 | Unknown | U | 0 | 500 | MG | TABLET | |||||||
| 127502401 | 12750240 | 13 | C | BICALUTAMIDE. | BICALUTAMIDE | 1 | Unknown | U | 0 | 50 | MG | TABLET | |||||||
| 127502401 | 12750240 | 14 | C | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | U | 0 | 500 | MG | TABLET | |||||||
| 127502401 | 12750240 | 15 | C | SULFAMETHOXAZOL | SULFAMETHOXAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | |||||||||
| 127502401 | 12750240 | 16 | C | Tamsulosin | TAMSULOSIN | 1 | Unknown | 0.4 MG, UNKNOWN FREQ. | U | 0 | .4 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127502401 | 12750240 | 1 | Product used for unknown indication |
| 127502401 | 12750240 | 3 | Product used for unknown indication |
| 127502401 | 12750240 | 4 | Product used for unknown indication |
| 127502401 | 12750240 | 5 | Product used for unknown indication |
| 127502401 | 12750240 | 6 | Product used for unknown indication |
| 127502401 | 12750240 | 7 | Product used for unknown indication |
| 127502401 | 12750240 | 8 | Product used for unknown indication |
| 127502401 | 12750240 | 9 | Product used for unknown indication |
| 127502401 | 12750240 | 10 | Product used for unknown indication |
| 127502401 | 12750240 | 11 | Product used for unknown indication |
| 127502401 | 12750240 | 12 | Product used for unknown indication |
| 127502401 | 12750240 | 13 | Product used for unknown indication |
| 127502401 | 12750240 | 14 | Product used for unknown indication |
| 127502401 | 12750240 | 15 | Product used for unknown indication |
| 127502401 | 12750240 | 16 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127502401 | 12750240 | Asthenia | |
| 127502401 | 12750240 | Breast enlargement | |
| 127502401 | 12750240 | Constipation | |
| 127502401 | 12750240 | Decreased appetite | |
| 127502401 | 12750240 | Dizziness | |
| 127502401 | 12750240 | Dysphonia | |
| 127502401 | 12750240 | Fall | |
| 127502401 | 12750240 | Fatigue | |
| 127502401 | 12750240 | Headache | |
| 127502401 | 12750240 | Nausea | |
| 127502401 | 12750240 | Sinusitis |
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 |
|---|---|---|---|---|---|---|
| 127502401 | 12750240 | 1 | 201604 | 0 | ||
| 127502401 | 12750240 | 2 | 20160512 | 0 |