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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126437422 | 12643742 | 2 | F | 201507 | 20160920 | 20160811 | 20160929 | EXP | US-AMGEN-USASP2016101088 | AMGEN | 75.00 | YR | E | M | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126437422 | 12643742 | 1 | PS | XGEVA | DENOSUMAB | 1 | Unknown | UNK | Y | 125320 | SOLUTION FOR INJECTION | ||||||||
| 126437422 | 12643742 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | 160 MG, QD | 0 | 160 | MG | QD | |||||||
| 126437422 | 12643742 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | 0 | ||||||||||||
| 126437422 | 12643742 | 4 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126437422 | 12643742 | 1 | Product used for unknown indication |
| 126437422 | 12643742 | 2 | Prostate cancer |
| 126437422 | 12643742 | 3 | Plasma cell myeloma |
| 126437422 | 12643742 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126437422 | 12643742 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126437422 | 12643742 | Asthenia | |
| 126437422 | 12643742 | Blood urine present | |
| 126437422 | 12643742 | Constipation | |
| 126437422 | 12643742 | Decreased appetite | |
| 126437422 | 12643742 | Depression | |
| 126437422 | 12643742 | Eating disorder | |
| 126437422 | 12643742 | Fatigue | |
| 126437422 | 12643742 | Flatulence | |
| 126437422 | 12643742 | Hot flush | |
| 126437422 | 12643742 | Hyperhidrosis | |
| 126437422 | 12643742 | Malignant neoplasm progression | |
| 126437422 | 12643742 | Paraesthesia | |
| 126437422 | 12643742 | Rhinorrhoea | |
| 126437422 | 12643742 | Tongue disorder | |
| 126437422 | 12643742 | Urinary bladder haemorrhage | |
| 126437422 | 12643742 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 126437422 | 12643742 | 1 | 201606 | 0 |