Mattiuzzi 2007.
Study characteristics | ||
Methods |
Randomised, phase 2 trial with 3 arms
Recruitment period: n.r.
Masking: n.r. Baseline patient characteristics: n.r. Follow‐up: n.r. |
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Participants |
Inclusion criteria: n.r. Exclusion criteria: n.r. Mean/median age (range), years: n.r. Gender: n.r. Tumour/cancer type: acute myeloid leukemia, myelodysplastic syndrome Chemotherapy regimen: MD‐HD‐CHEMO with HDAC‐containing regimens Country: n.r. |
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Interventions |
Experimental: arm A: ONDA 1 to 5 ONDA 8 mg i.v. bolus, then 24 mg i.v., continuous infusion on Day 1 through Day 5 and for 12 h after Ara C infusion ends Experimental: arm B: PALO 1 to 5 PALO 0.25 mg i.v. bolus over 30 seconds on Day 1 through Day 5 of Ara C infusion Experimental: arm C: PALO 1, 3, 5 PALO 0.25 mg i.v. bolus over 30 seconds on Days 1, 3, and 5 of Ara C infusion All patients received Solumedrol 40 mg i.v. before Ara C |
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Outcomes |
Primary endpoint(s)
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: randomised trial but method of randomisation not described |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not reported |
Blinding of participants and personnel (performance bias) Blinding of participants | High risk | Quote: "open randomized comparative trial" |
Blinding of participants and personnel (performance bias) Blinding of personnel | High risk | Quote: "open randomized comparative trial" |
Blinding of outcome assessment (detection bias) Subjective outcomes (Patient reported outcomes) | High risk | Comment: patients and personnel were not blinded towards the intervention and therefore might influence subjective outcomes analysis |
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes) | Low risk | Comment: 95 patients were evaluable |
Selective reporting (reporting bias) | Low risk | Comment: all outcome measures were reported in the results section |
Other bias | Unclear risk | Comment: conference abstract, not evaluable |