Vogler 1992.
Methods | Design:
Recruitment period:
Median follow‐up:
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Participants | Eligibility criteria:
Patients randomised (n = 230)
Median age:
Gender (male, female):
Country:
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Interventions | IDA arm: IA regimen, 1 to 2 cycles
DNR arm: DA regimen, 1 to 2 cycles
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Outcomes | Outcomes and time‐points from the study that are considered in the review:
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Notes | Published as a journal article Funded in part by Adria Laboratories, the manufacturer of idarubicin No conflict of interest statement Updated data were published in 1997 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were assigned randomly to" Comment: the study probably had an adequate sequence generation |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) Overall survival | Low risk | Comment: the review authors judge that the outcome OS is unlikely to be influenced by lack of blinding |
Blinding (performance bias and detection bias) All other outcomes | High risk | Comment: blinding was not explicitly stated |
Incomplete outcome data (attrition bias) OS and DFS | Low risk | Quote: "No. of patients randomized: IDR 111, DNR 119", "Exclusions: Wrong diagnosis: IDR 2, DNR 1; Protocol violations: IDR 4, DNR 2; Randomized, not treated: DNR 1; Died before treatment: DNR 2" Comment: the small number of missing outcome data were balanced in numbers across intervention groups, with similar reasons for missing data across groups |
Selective reporting (reporting bias) | Unclear risk | Comment: the study has no registered study protocol. The review authors have no information to permit judgement |
Other bias | High risk | Comment: baseline characteristics of patients were imbalanced in platelet count. The median platelet count was significantly higher on the IDA arm (P value = 0.023) |