Solid tumors
Conditions
Interventions
None listed
Sponsors
Yokohama City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will include only English full-articles. The other article including non-English article, short article, and conference abstract will be excluded. We will include parallel-group individual randomized controlled trials (RCTs) but not cluster RCTs, or cross-over RCTs. A trial with three or more arms will be accepted. Along with superiority trials, non-inferiority trials will be allowed. Any phase RCT may be included. Trials not reporting data about safety outcomes will be excluded. Key inclusion criteria are as follows. (1) RCTs including ICI-containing arm and control arm in adult patients. Controls were classified as placebo or non-placebo. Non-placebo drugs were defined as any anticancer drugs. (2) The study with multiple arms where ICI is included at least one arm. (3) The study illustrates the outcome of hematological AEs.
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. Two investigators independently screened all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The odds ratio (OR) of any grade hematological AEs will be calculated. Meta-analysis will be performed to compare the incidence of hematological AEs between ICI-containing arm and control arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of hematological AEs will be pooled using random-model meta-analysis. | — |
Countries
Japan
Contacts
Public ContactKaoru Minegishi
Yokohama City University Graduate School of Medicine Department of Stem Cell and Immune Regulation
Outcome results
None listed