Ho 2010.

Study characteristics
Methods	Randomised, parallel, comparative, active‐control trial with 2 arms comparison of ramosetron + dexamethasone vs granisetron + dexamethasone Recruitment period: January 2006 to December 2007 288 patients enrolled 287 patients randomised 262 patients evaluable Masking: double‐blind Baseline patient characteristics: reported Follow‐up: n.r.
Participants	Inclusion criteria 20 to 74 years old (inclusive) of either sex i.v. infusion, alone in 1 single dose or combined with other chemotherapy regimens: cisplatin ≥ 50 mg/m², with infusion time 2 h ± 10 min; doxorubicin ≥ 50 mg/m², with infusion time ≤ 1 h; epirubicin ≥ 60 mg/m², with infusion time ≤ 1 h; and oxaliplatin ≥ 65 mg/m², with infusion time 2 h ± 10 min no symptoms of vomiting for at least 1 week before dosing trial medication Eastern Cooperative Oncology Group (ECOG) performance status scale no greater than 2 (ECOG 2) Exclusion criteria had received radiotherapy to abdomen or pelvis within 4 weeks before entering this study had received chemotherapy including 1 of 4 regimens, namely, cisplatin, doxorubicin, epirubicin, or oxaliplatin, within 6 months before entering the study known heart failure or myocardial infarction or laboratory abnormalities at screening including serum creatinine more than 2 × ULN, AST and ALT more than 3 × ULN  known concurrent disease that may cause vomiting, such as gastrointestinal tract obstruction, epilepsy, brain metastasis, brain tumour, or intracranial hypertension had taken medications that could influence the outcome of the study within 3 days before entering the study, such as antiepilepsy drugs, antiemetics, antipsychotics, or adrenocorticoids history of allergy or intolerance to ramosetron, granisetron, or dexamethasone pregnant or breast‐feeding life expectancy < 3 months participated in other investigational drug trial within 1 month before entering this study Median age (range), years: 51 (29 to 73) in ramosetron + dexamethasone group, 51 (22 to 74) in granisetron + dexamethasone group Gender: male (110) + female (175) Tumour/cancer type: solid malignancy (breast, lung, nasopharynx, mouth, rectum, liver, bladder, stomach, oesophagus, testis, brain, other) Chemotherapy regimen: cisplatin, doxorubicin, epirubicin, or oxaliplatin Country: Taiwan (4 centres)
Interventions	Experimental: arm A: ramosetron + dexamethasone ramosetron 0.3 mg + dexamethasone 20 mg Experimental: arm B: granisetron + dexamethasone granisetron 3 mg + dexamethasone 20 mg
Outcomes	Primary endpoint complete response (CR) rate (24 h after the start of chemotherapy) Secondary endpoint(s) To be evaluated during first, second, third, and fourth 6‐h durations and total 24‐h period after the start of chemotherapy proportion of patients with vomiting nausea degree evaluated by patient’s 10‐cm visual analogue scale (VAS) total control rate with no vomiting plus nausea VAS 0.5 cm proportion of subjects that had received rescue drug(s)
Notes	"this trial was sponsored by Astellas Pharma Taiwan, Inc." conflicts of interest: "none declared"
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	Low risk	Quote: "... double‐blind ..."
Blinding of participants and personnel (performance bias) Blinding of personnel	Low risk	Quote: "... double‐blind ..."
Blinding of outcome assessment (detection bias) Subjective outcomes (Patient reported outcomes)	Low risk	Comment: both patients and personnel were blinded towards the intervention and thus had no influence on outcome assessment
Blinding of outcome assessment (detection bias) Objective outcomes (including mortality and safety)	Low risk	Comment: Both patients and personnel were blinded towards the intervention and thus had no influence on outcome assessment (e.g. hiccups)
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes)	Low risk	Comment: all patients were included for the efficacy analysis
Incomplete outcome data (attrition bias) Objective outcomes (including mortality and safety data)	Low risk	Comment: safety data were reported for all randomised patients who received the study drug
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