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Women get more severe side effects than men at identical doses of fluorouracil, several kinase inhibitors and immune checkpoint inhibitors in pooled analyses. Trials should pre-specify sex-stratified drug level and toxicity analyses and, where they differ, run sex-specific dose-finding and label accordingly.
Registrational trials pre-specify sex-stratified PK, exposure-response and toxicity analyses; where exposure or toxicity differs, dose-finding includes sex-specific cohorts and labels carry sex-specific guidance. Fluorouracil, several TKIs and immune checkpoint inhibitors show sex differences in toxicity in pooled analyses; the mechanism (body composition, clearance, immune biology) varies by drug.
Shares Wrong doses, Toxicity and quality of life are undervalued, Small-molecule kinase inhibitors.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Shares Wrong doses, Toxicity and quality of life are undervalued, Small-molecule kinase inhibitors.
Shares Wrong doses, Toxicity and quality of life are undervalued, Small-molecule kinase inhibitors.
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.