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. 2015 Jun 3;2015(6):CD010432. doi: 10.1002/14651858.CD010432.pub2

Vogler 1992.

Methods Design:
  • RCT with two arms: IDA versus DNR


Recruitment period:
  • December 1985 to January 1989


Median follow‐up:
  • not stated

Participants Eligibility criteria:
  • > 14 years

  • previously untreated AML defined by FAB criteria

  • normal cardiac ejection fraction as determined by the normal value at each of the participating institutions


Patients randomised (n = 230)
  • IDA arm: n = 111

  • DNR arm: n = 119


Median age:
  • IDA arm: 60 years (range not stated)

  • DNR arm: 61 years (range not stated)


Gender (male, female):
  • IDA arm: n = 56, n = 49

  • DNR arm: n = 53, n = 60


Country:
  • United States, 16 centres

Interventions IDA arm: IA regimen, 1 to 2 cycles
  • IDA: 12 mg/m²/d for 3 days, IV

  • Ara‐C: 100 mg/m²/d for 7 days, IV


DNR arm: DA regimen, 1 to 2 cycles
  • DNR: 45 mg/m²/d for 3 days, IV

  • Ara‐C: 100 mg/m²/d for 7 days, IV

Outcomes Outcomes and time‐points from the study that are considered in the review:
  • reported: OS, DFS, CR, death on induction therapy, relapse, AEs

  • not reported: quality of life

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
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)