Kang 2020.
Study characteristics | ||
Methods |
Randomised trial with 2 arms
Enrolment period: August 2015 to September 2017
Masking: single‐blind Baseline patient characteristics: reported Follow‐up: n.r. |
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Participants |
Inclusion criteria
Exclusion criteria
Mean age (SD), years: 59.4 (12.0) in ramosetron group, 60.3 (11.8) in palonosetron group Gender: 37.2% (62.8% male) female in ramosetron group, 38.7% female (61.3% male) in palonosetron group Tumour/cancer type: solid tumours (lung and thymus, breast, head and neck, gynaecological and genitourinary, gastrointestinal, others) Chemotherapy regimen: individual highly emetogenic chemotherapies: 71.5% in ramosetron group, 72.5% in palonosetron group received cisplatin Country: Korea, multi‐centre |
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Interventions |
Experimental: arm A: ramosetron aprepitant (Day 1, 125 mg p.o. 1 h before chemotherapy; Days 2 to 3, 80 mg p.o.), ramosetron (Day 1, 0.3 mg i.v. 30 min before chemotherapy), and dexamethasone (Day 1, 12 mg p.o. or i.v. 30 min before chemotherapy; Days 2 to 4, 8 mg p.o.) Experimental: arm B: palonosetron aprepitant (Day 1, 125 mg p.o. 1 h before chemotherapy; Days 2 to 3, 80 mg p.o.), palonosetron (Day 1, 0.25 mg i.v. 30 min before chemotherapy), and dexamethasone (Day 1, 12 mg p.o. or i.v. 30 min before chemotherapy; Days 2 to 4, 8 mg p.o.) |
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Outcomes |
Primary endpoint
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: "stratified block randomization was conducted with a 1:1 ratio between groups, randomly mixing block sizes of 2 and 4, considering (1) chemotherapeutic regimen (cisplatin vs.non‐cisplatin), (2) treatment schedule (single‐day vs. multiple‐ day), and (3) sex (male vs. female), as stratification factors"; "patients were assigned according to a pre‐defined randomization sequence created by an independent investigator with no clinical involvement in the trial" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) Blinding of participants | Low risk | Single‐blinded; participants were not aware of treatment |
Blinding of participants and personnel (performance bias) Blinding of personnel | High risk | Physicians were aware of treatment |
Blinding of outcome assessment (detection bias) Subjective outcomes (Patient reported outcomes) | Low risk | Outcome assessors (participants) were blinded to intervention |
Blinding of outcome assessment (detection bias) Objective outcomes (including mortality and safety) | Low risk | Outcome was robust to blinding |
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes) | High risk | Modified ITT was analysed (participants who received at least 1 treatment) |
Incomplete outcome data (attrition bias) Objective outcomes (including mortality and safety data) | High risk | Safety population (ITT) analysed, but not all participants received intervention |
Selective reporting (reporting bias) | Low risk | No reasons for any concerns detected |
Other bias | Low risk | No other sources of bias detected |