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

Ozaki 2013.

Study characteristics
Methods Randomised, phase 2 study with 2 arms

  • comparison of aprepitant + palonosetron + dexamethasone vs palonosetron + dexamethasone


Enrolment period: August 2011 to March 2013

  • 60 patients enrolled and randomised


Masking: n.r.
Baseline patient characteristics: n.r.
Follow‐up: n.r.
Participants Inclusion criteria: n.r.
Exclusion criteria: n.r.
Mean/median age, years: n.r.
Gender: n.r.
Tumour/cancer type: colorectal cancer
Chemotherapy regimen: standard MEC regimen
Country: Japan (multi‐centre)
Interventions Experimental: arm A: aprepitant
aprepitant + palonosetron + dexamethasone
Control: arm B
palonosetron + dexamethasone
Outcomes Primary endpoint

  • proportion of complete response


Secondary endpoint(s)

  • proportions of complete protection

  • no vomiting

  • no rescue medication

  • no nausea

  • no nausea at least moderate

  • time to treatment failure

  • dietary intake situation
Notes

  • conference abstract

  • "no conflict of interest"
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 Unclear risk Comment: blinding not reported
Blinding of participants and personnel (performance bias)
Blinding of personnel Unclear risk Comment: blinding not reported
Blinding of outcome assessment (detection bias)
Subjective outcomes (Patient reported outcomes) Unclear risk Comment: blinding not reported
Incomplete outcome data (attrition bias)
Subjective outcomes (Patient reported outcomes) High risk Quote: "fifteen patients were excluded because of insufficient diary and protocol violation. Finally, we analyzed 45 patients (26 male, 19 female) for this study"
Comment: the percentage of excluded patients was 25% of the initial included population
Selective reporting (reporting bias) Unclear risk Comment: only complete response was reported in detail; other secondary outcomes were not reported with statistical figures, as no significant differences were observed between the 2 groups. Conference abstract only, not evaluable
Other bias Unclear risk Comment: conference abstract, not evaluable