Pautas 2010.

Methods	Design: RCT with three arms: IDA3 versus IDA4 versus DNR Recruitment period: December 1999 to September 2006 Median follow‐up: 49 months (range not stated)
Participants	Eligibility criteria: Inclusion criteria: 50 to 70 years newly diagnosed non‐M3‐AML no severe heart, liver, or renal dysfunction Exclusion criteria: prior myeloproliferative or documented MDS prior exposure to chemotherapy or radiotherapy Patients randomised (n = 478) IDA3 arm: n = 160 IDA4 arm: n = 158 DNR arm: n = 160 Median age: IDA3 arm: 60 years (range not stated) IDA4 arm: 60 years (range not stated) DNR arm: 60 years (range not stated) Gender (male, female): IDA3 arm: n = 89, n = 66 IDA4 arm: n = 89, n = 68 DNR arm: n = 81, n = 75 Country: France, multicentre
Interventions	IDA3 arm: IA regimen, 1 cycle IDA: 12 mg/m²/d for 3 days, IV Ara‐C: 200 mg/m²/d for 7 days, IV IDA4 arm: IA regimen, 1 cycle IDA: 12 mg/m²/d for 4 days, IV Ara‐C: 200 mg/m²/d for 7 days, IV DNR arm: DA regimen, 1 cycle DNR: 80 mg/m²/d for 3 days, IV Ara‐C: 200 mg/m²/d for 7 days, IV
Outcomes	Outcomes and time‐points from the study that are considered in the review: reported: OS, CR, death on induction therapy, relapse, AEs not reported: DFS, quality of life
Notes	Published as a journal article Funded in part by Assistance Publique‐Hopitaux de Paris and the Programme Hospitalier de Recherche Clinique The authors declared no potential conflict of interest
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "patients were randomly assigned 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	Quote (from registered protocol): "Open Label" Comment: patient and physician unblinded
Incomplete outcome data (attrition bias) OS and DFS	Low risk	Quote: "statistical analysis was performed on an intention‐to‐treat basis, using three‐arm comparisons"; "478 patients were included (Fig 1). Ten patients were excluded for misdiagnosis. Final analysis included 468 patients"; "Excluded: misdiagnosed DNR (n = 4) IDA3 (n = 5) IDA4 (n = 1)" 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)	Low risk	Comment: protocol is available (ClinicalTrial.gov: NCT00931138) Pre‐defined outcomes (relevant for the review) that were reported: AEs Pre‐defined outcomes (relevant for the review) that were not reported: none Reported outcomes (relevant for the review) that were not predefined in the protocol: OS CR death on induction therapy relapse
Other bias	Unclear risk	No information provided