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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127506831 | 12750683 | 1 | I | 201512 | 20160111 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US001122 | ASTELLAS | 79.53 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127506831 | 12750683 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 203415 | CAPSULE | ||||||||
| 127506831 | 12750683 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | 203415 | 3 | DF | CAPSULE | QD | |||||||
| 127506831 | 12750683 | 3 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127506831 | 12750683 | 4 | C | ZYTIGA | ABIRATERONE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127506831 | 12750683 | 1 | Prostate cancer metastatic |
| 127506831 | 12750683 | 3 | Product used for unknown indication |
| 127506831 | 12750683 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127506831 | 12750683 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127506831 | 12750683 | Asthenia | |
| 127506831 | 12750683 | Constipation | |
| 127506831 | 12750683 | Decreased appetite | |
| 127506831 | 12750683 | Diarrhoea | |
| 127506831 | 12750683 | Hot flush | |
| 127506831 | 12750683 | Prostatic specific antigen increased | |
| 127506831 | 12750683 | Rash | |
| 127506831 | 12750683 | 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 |
|---|---|---|---|---|---|---|
| 127506831 | 12750683 | 1 | 20150730 | 0 | ||
| 127506831 | 12750683 | 2 | 20151104 | 0 | ||
| 127506831 | 12750683 | 4 | 20150729 | 0 |