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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126705561 | 12670556 | 1 | I | 20160808 | 20160822 | 20160822 | EXP | JP-CIPLA LTD.-2016JP17218 | CIPLA | KOIE T, OHYAMA C, YAMAMOTO H, IMAI A, HATAKEYAMA S, YONEYAMA T ET AL.. NEOADJUVANT GEMCITABINE AND CARBOPLATIN FOLLOWED BY IMMEDIATE CYSTECTOMY MAY BE ASSOCIATED WITH A SURVIVAL BENEFIT IN PATIENTS WITH CLINICAL T2 BLADDER CANCER. MED ONCOL. 2014;31:949 | 0.00 | Y | 0.00000 | 20160822 | OT | JP | JP |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126705561 | 12670556 | 1 | PS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | AUC 4, TWO CYCLES EACH CYCLE LASTED FOR 21 DAYS | 77383 | ||||||||||
126705561 | 12670556 | 2 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | 800 MG/M2, TWO CYCLES, ON DAYS 1, 8 AND 15 | 0 | 800 | MG/M**2 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126705561 | 12670556 | 1 | Bladder cancer |
126705561 | 12670556 | 2 | Bladder cancer |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126705561 | 12670556 | DE |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126705561 | 12670556 | Death |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |