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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125488872 | 12548887 | 2 | F | 20160609 | 20160811 | 20160712 | 20160815 | EXP | FR-ASTELLAS-2016US026432 | ASTELLAS | 82.12 | YR | M | Y | 0.00000 | 20160815 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125488872 | 12548887 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG, DAILY | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 2 | SS | CASODEX | BICALUTAMIDE | 1 | Oral | 1 DF, DAILY | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 3 | SS | LACTULOSE. | LACTULOSE | 1 | Oral | 2 DF, DAILY | 0 | 2 | DF | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 4 | SS | OXYNORMORO | OXYCODONE | 1 | Oral | 5 MG, IF NECESSARY | 0 | 5 | MG | FORMULATION UNKNOWN | |||||||
| 125488872 | 12548887 | 5 | SS | BISOPROLOL EG | BISOPROLOL | 1 | Oral | 1.25 MG, DAILY | 0 | 1.25 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 6 | SS | NICORANDIL BIOGARAN | NICORANDIL | 1 | Oral | 1 DF, DAILY | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 7 | SS | KARDEGIC | ASPIRIN LYSINE | 1 | Oral | 1 DF, DAILY | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 8 | SS | DIFFU K | POTASSIUM CHLORIDE | 1 | Oral | 1 DF, DAILY | 10 | DF | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||
| 125488872 | 12548887 | 9 | SS | ESOMEPRAZOLE EG | ESOMEPRAZOLE | 1 | Oral | 1 DF, DAILY | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 1 MG, DAILY | 0 | 1 | MG | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 11 | SS | PRAVASTATINE EG | PRAVASTATIN SODIUM | 1 | Oral | 1 DF, DAILY | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 12 | SS | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Oral | 1 DF, DAILY | 0 | 1 | DF | FORMULATION UNKNOWN | QD | ||||||
| 125488872 | 12548887 | 13 | SS | DOLIPRANE | ACETAMINOPHEN | 1 | Oral | 1 G, IF NECESSARY | 0 | 1 | G | FORMULATION UNKNOWN | |||||||
| 125488872 | 12548887 | 14 | SS | NORMACOL /00086101/ | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Rectal | UNK, IF NECESSARY | 0 | FORMULATION UNKNOWN | |||||||||
| 125488872 | 12548887 | 15 | SS | OXYCONTIN | OXYCODONE HYDROCHLORIDE | 1 | Oral | 0 | 1 | DF | FORMULATION UNKNOWN | BID | |||||||
| 125488872 | 12548887 | 16 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125488872 | 12548887 | 17 | C | LYSANXIA | PRAZEPAM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125488872 | 12548887 | 1 | Prostate cancer |
| 125488872 | 12548887 | 2 | Prostate cancer |
| 125488872 | 12548887 | 3 | Constipation |
| 125488872 | 12548887 | 4 | Pain |
| 125488872 | 12548887 | 5 | Hypertension |
| 125488872 | 12548887 | 6 | Angina unstable |
| 125488872 | 12548887 | 7 | Cardiovascular event prophylaxis |
| 125488872 | 12548887 | 8 | Hypokalaemia |
| 125488872 | 12548887 | 9 | Gastrooesophageal reflux disease |
| 125488872 | 12548887 | 10 | Product used for unknown indication |
| 125488872 | 12548887 | 11 | Hypercholesterolaemia |
| 125488872 | 12548887 | 12 | Diabetes mellitus |
| 125488872 | 12548887 | 13 | Pain |
| 125488872 | 12548887 | 14 | Constipation |
| 125488872 | 12548887 | 15 | Pain |
| 125488872 | 12548887 | 16 | Product used for unknown indication |
| 125488872 | 12548887 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125488872 | 12548887 | HO |
| 125488872 | 12548887 | DE |
| 125488872 | 12548887 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125488872 | 12548887 | Hepatic encephalopathy | |
| 125488872 | 12548887 | Hepatic function abnormal | |
| 125488872 | 12548887 | Hepatorenal syndrome | |
| 125488872 | 12548887 | Renal failure |
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 |
|---|---|---|---|---|---|---|
| 125488872 | 12548887 | 1 | 20160524 | 0 | ||
| 125488872 | 12548887 | 2 | 20160210 | 0 | ||
| 125488872 | 12548887 | 3 | 20160528 | 0 | ||
| 125488872 | 12548887 | 4 | 20160526 | 0 | ||
| 125488872 | 12548887 | 5 | 20151127 | 0 | ||
| 125488872 | 12548887 | 8 | 20160528 | 20160606 | 0 | |
| 125488872 | 12548887 | 9 | 20160606 | 0 | ||
| 125488872 | 12548887 | 10 | 20160606 | 0 | ||
| 125488872 | 12548887 | 11 | 20160606 | 0 | ||
| 125488872 | 12548887 | 12 | 20160606 | 0 | ||
| 125488872 | 12548887 | 14 | 20160507 | 0 | ||
| 125488872 | 12548887 | 15 | 20160526 | 0 | ||
| 125488872 | 12548887 | 17 | 20160610 | 0 |