Solid tumors
Conditions
Interventions
None listed
Sponsors
Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel Department of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The published study designed as a randomized clinical trial (RCT). (2) The experimental group of the study was treated with at least one type of ICIs with or without other systemic chemotherapy and the control group of the study was treated with systemic chemotherapy including cytotoxic chemotherapy, ICI, and molecular-targeting therapy, ICI-placebo, or best supportive care (BSC). (3) The study with three arms where ICI is included at least one arm. (4) The patients were clinically diagnosed with any solid tumor. (5) The study illustrates the outcome of pneumonitis, all adverse events (AEs), and grade 3-5 AEs. (6) Only full-text papers are used to analyze.
Exclusion criteria
Exclusion criteria: (1) Systematic review or meta-analysis articles. (2) Retrospective analysis. (3) Single prospective cohort study without a control group. (4) Non-RCT. (5) The republished research literature is excluded unless the research includes new findings related to adverse events listed in inclusion criteria. (6) Studies with no or insufficient safety results at the time of the literature search. (7) Studies published in languages other than English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare the incidence of pneumonitis induced by adding immune checkpoint inhibitors to other therapy and to analyze the contribution of a specific type of immune checkpoint inhibitors to the AE. The total number of participants is used as a denominator when calculating the incidence of pneumonitis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcomes will be defined: occurrence of all grades pneumonitis events and the occurrence of grade 3 and more pneumonitis events. | — |
Countries
Japan,North America
Contacts
Public ContactYu Fujiwara
Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel Department of Medicine
Outcome results
None listed