Kimura 2015.
Study characteristics | ||
Methods |
Randomised, cross‐over trial with 2 arms
Enrolment period: 1 April 2011 to 31 March 2013
Masking: single‐blind Baseline patient characteristics: reported Follow‐up: patients were followed up for 10 days during each course for efficacy and safety endpoints |
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Participants |
Inclusion criteria
Exclusion criteria
Age (range), years: 36.1 (15 to 65) in palonosetron arm, 50.6 (18 to 70) in granisetron arm Gender: male + female Tumour/cancer type: osteosarcoma, malignant fibrous histiocytoma, synovial sarcoma, leiomyosarcoma, rhabdomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, clear cell sarcoma Chemotherapy regimen: cisplatin + doxorubicin, ifosfamide + doxorubicin/ifosfamide + etoposide Country: Japan |
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Interventions |
Cross‐over study Experimental: arm A: palonosetron Day 1: p.o. 125 mg aprepitant + i.v. 0.75 mg palonosetron + i.v. 6.6 mg dexamethasone Days 2 to 5: 80 mg aprepitant + 6.6 mg dexamethasone Experimental: arm B: granisetron Day 1: p.o. 125 mg aprepitant + i.v. 3 mg × 2 granisetron + i.v. 6.6 mg dexamethasone Days 2 to 5: 80 mg aprepitant + 3 mg × 2 granisetron + 6.6 mg dexamethasone |
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Outcomes |
Primary endpoints
Secondary endpoints
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a single randomization method was used to assign eligible patients to the palonosetron or granisetron arm" |
Allocation concealment (selection bias) | Unclear risk | Commen: allocation concealment not reported |
Blinding of participants and personnel (performance bias) Blinding of participants | Low risk | Quote: "all participants were blinded to the antiemetic treatment assignments for the duration of the study" |
Blinding of participants and personnel (performance bias) Blinding of personnel | High risk | Comment: only patients were blinded to the study intervention |
Blinding of outcome assessment (detection bias) Subjective outcomes (Patient reported outcomes) | High risk | Comment: although patients were blinded, unblinded personnel might have an influence on outcome assessment |
Blinding of outcome assessment (detection bias) Objective outcomes (including mortality and safety) | Low risk | Comment: although this was a single‐blind study, we assume that both patients and personnel had no influence on objective outcomes (e.g. hiccups) |
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes) | Low risk | Quote: "all patients were eligible for efficacy analysis ..." |
Incomplete outcome data (attrition bias) Objective outcomes (including mortality and safety data) | Low risk | Quote: "safety was assessed for all patients who received treatment" |
Selective reporting (reporting bias) | Low risk | Comment: all outcome measures were reported in the results section |
Other bias | Low risk | Comment: no information to suggest other sources of bias |