Ando 2016.
Study characteristics | ||
Methods |
Randomised, controlled study with 2 arms
Recruitment period: January 2013 to March 2014
Masking: open‐label Baseline patient characteristics: reported Follow‐up: n.r. |
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Participants |
Inclusion criteria
Exclusion criteria
Mean age ± SD, years: 61.7 ± 11.7 in aprepitant group, 65.4 ± 10.0 in fosaprepitant group Gender: male (74) + female (19) Tumour/cancer type: malignant tumour (lung cancer, gastric cancer, oesophageal cancer, head and neck cancer) Chemotherapy regimen: CDDP (60 mg/m² or higher) Country: Japan (single centre) |
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Interventions |
Experimental: arm A: aprepitant Day 1: aprepitant 125 mg + palonosetron 0.75 mg or granisetron 3 mg or azasetron 10 mg + dexamethasone 6.6 to 9.9 mg Days 2 to 4: aprepitant 80 mg + dexamethasone 3.3 to 6.6 mg Day 5: aprepitant 80 mg Experimental: arm B: fosaprepitant Day 1: fosaprepitant meglumine 150 mg + palonosetron 0.75 mg or granisetron 3 mg or azasetron 10 mg + dexamethasone 6.6 to 9.9 mg Days 2 to 4: dexamethasone 3.3 to 6.6 mg |
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Outcomes |
Primary endpoint
Secondary 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 reported |
Allocation concealment (selection bias) | Unclear risk | Comment: no allocation concealment reported |
Blinding of participants and personnel (performance bias) Blinding of participants | High risk | Quote: "... open‐label ..." |
Blinding of participants and personnel (performance bias) Blinding of personnel | High risk | Quote: "... open‐label ..." |
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: all randomised patients were included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: in the results section, palonosetron, granisetron, and azasetron were not separately reported |
Other bias | Low risk | Comment: no information to suggest other sources of bias |