The Safety Rates Drug Report

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Drug     Injury     Quarter    

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
125425041 12542504 1 I 20160624 20160709 20160709 EXP GB-CIPLA LTD.-2016GB08985 CIPLA CRABB SJ, BRADBURY J, NOLAN L, SELMAN D, MUTHURAMALINGAM SR, CAVE J, ET AL. A PHASE I CLINICAL TRIAL OF IRINOTECAN AND CARBOPLATIN IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER. CHEMOTHERAPY. 2012;58:257 TO 263 0.00 Y 0.00000 20160709 OT GB GB

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
125425041 12542504 1 PS Irinotecan IRINOTECAN 1 Intravenous (not otherwise specified) 60 MG/M2, ON DAYS 1 AND 8 U U 0 60 MG/M**2 INFUSION
125425041 12542504 2 SS CARBOPLATIN. CARBOPLATIN 1 Intravenous (not otherwise specified) AUC OF 5 ON DAY 1 U U 0 INFUSION
125425041 12542504 3 SS CARBOPLATIN. CARBOPLATIN 1 Unknown UNK U U 0 INFUSION
125425041 12542504 4 SS ETOPOSIDE. ETOPOSIDE 1 Unknown UNK U U 0
125425041 12542504 5 C ATROPINE. ATROPINE 1 Unknown UNK U U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125425041 12542504 1 Small cell lung cancer extensive stage
125425041 12542504 2 Small cell lung cancer extensive stage
125425041 12542504 4 Small cell lung cancer extensive stage
125425041 12542504 5 Prophylaxis

Outcome of event

Event ID CASEID OUTC COD
125425041 12542504 OT
125425041 12542504 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
125425041 12542504 Death
125425041 12542504 Disease progression

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found