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. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

Mattiuzzi 2007.

Study characteristics
Methods Randomised, phase 2 trial with 3 arms
  • comparison of ondansetron Days 1 to 5 + dexamethasone vs palonosetron Days 1 to 5 + dexamethasone vs palonosetron Days 1, 3, and 5 + dexamethasone


Recruitment period: n.r.
  • n = 95


Masking: n.r.
Baseline patient characteristics: n.r.
Follow‐up: n.r.
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.
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
Outcomes Primary endpoint(s)
  • complete response

  • complete control

Notes
  • abstract only

  • "disclosure: consultancy: MGI, Pfizer, Merck. Research funding: Astellas, MGI, Novartis"

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