Harousseau 1996.

Methods	Design: RCT with two arms: IDA versus ZRB Recruitment period: November 1987 to May 1994 Median follow‐up: 48 months (range not stated)
Participants	Eligibility criteria: Inclusion criteria: 15 to 65 years previously untreated AML identified by the FAB criteria Exclusion criteria: previously diagnosed MDS for more than 3 months myeloproliferative disorder in blast crisis previously received cytotoxic chemotherapy or radiotherapy (or both) with clinical or electric signs of heart failure or coronary disease with hepatic or renal disturbances (hepatic enzymes levels over four times the normal values, creatinine level over 130 micromoles per litre) Patients randomised, analysed (n = 786) IDA arm: n = 393 ZRB arm: n = 393 Median age: IDA arm: not stated ZRB arm: not stated Gendar (male, female): IDA arm: not stated ZRB arm: not stated Country: France, multicentre
Interventions	IDA arm: IA regimen, 1 to 2 cycles First cycle: IDA: 8 mg/m²/d, days 1 to 5, IV Ara‐C: 200 mg/m²/d, days 1 to 7, IV Second cycle: IDA: 8 mg/m²/d for 2 days, IV Ara‐C: 200 mg/m²/d for 3 days, IV ZRB arm: ZA regimen, 1 to 2 cycles First cycle: ZRB: 200 mg/m²/d, days 1 to 4, IV Ara‐C 200 mg/m²/d, days 1 to 7, IV Second cycle: ZRB: 200 mg/m²/d for 2 days, IV Ara‐C: 200 mg/m²/d for 3 days, IV
Outcomes	Outcomes and time‐points from the study that are considered in the review: reported: CR, death on induction therapy not reported: OS, DFS, relapse, AEs, quality of life
Notes	Published as a journal article Funded by Programme Hospitalier de Recherche Clinique No conflict of interest statement
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Patients (...) were randomized between" 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	Unclear risk	Not reported
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: "A total of 786 patients were included into the study by 16 institutions (IDR: 393, ZRB: 393). However 28 patients were considered ineligible (IDR: 11, ZRB: 17), 16 for an inadequate diagnosis, 8 because they were off age limits and 4 for other ineligibility criteria. Moreover, 27 patients were unable to evaluate for remission induction treatment, 9 because they died before the first day of treatment, 13 because of major protocol violation, 4 because of wrong randomisation, 1 because of missing data" Comment: as the missing data concern a small proportion of the study population (55 out of 786 patients, 7.0%), we judged this study as low risk of bias for incomplete outcome data
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	Unclear risk	No information provided