Cheirsilpa 2005.

Study characteristics
Methods	Randomised controlled trial with 2 arms comparison of ramosetron + dexamethasone vs granisetron + dexamethasone Enrolment period: February 2003 to August 2003 73 patients enrolled and randomised Masking: double‐blind Baseline patient characteristics: reported Follow‐up: n.r.
Participants	Inclusion criteria 20 to 80 years of age first course of CDDP chemotherapy ≥ 70 mg/m² with single‐ or multiple‐dose regimen (Days 1, 2, 3, 4, and 5) treatment with steroids in these patients allowed if such drugs were part of the chemotherapy regimen Exclusion criteria any disorders causing nausea brain tumour, brain metastasis, and epilepsy concomitant disease that may cause vomiting (e.g. active peptic ulcer, gastric outlet obstruction, intestinal obstruction) complications with severe disorder of the heart, kidney, and liver pregnant or possibly pregnant took drugs that may affect the gastrointestinal tract or central nervous system within 24 h before the start of the study (e.g. other antiemetics, psychotropic drugs) or had experienced vomiting in the previous 24 h Mean age ± SD, years: ramosetron group 54.53 ± 10.16, granisetron group 53.97 ± 10.50 Gender: male + female Tumour/cancer type: solid malignancy (head and neck, cervix, lung, ovary, stomach‐oesophagus, urinary bladder, testis, other) Chemotherapy regimen: cisplatin at dose ≥ 70 mg/m² Country: Thailand (single centre)
Interventions	Experimental: arm A: ramosetron i.v. ramosetron (0.3‐mg bolus) on Day 1, 30 min before receiving cisplatin oral preparation of ramosetron (0.1‐mg tablet) on Days 2 to 5, in the morning or 1 h before receiving cisplatin 20 mg dexamethasone before cisplatin administration Active control: arm B: granisetron i.v. granisetron (3‐mg infusion) on Day 1 30 min before receiving cisplatin oral preparation of granisetron (1‐mg tablet) on Days 2 to 5, in the morning or 1 h before receiving cisplatin 20 mg dexamethasone before cisplatin administration
Outcomes	Primary endpoint inhibition of acute and delayed nausea (measured on a 4‐grade scale every 6 h after administration of study drug) Secondary endpoints inhibition of acute and delayed vomiting (time points for vomiting were observed and recorded for 24 h after administration of study drug; frequency of vomiting was recorded every 6 h after administration) response rate of study drug (evaluated on a 4‐grade scale based on the condition of nausea and vomiting according to criteria for evaluation of response rate in the period 0 to 24 h after administration adverse events (nature, duration, severity, clinical course, and measures taken were recorded)
Notes	this study was supported by Yamanouchi (Thailand) no protocol registration identifier is provided study authors did not provide disclosure of potential conflicts 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 reported
Allocation concealment (selection bias)	Low risk	Quote: "... one nurse prepared for the study drug using identical syringes. The study drug was then sent to another nurse confirming that the study drug was stable and identical in appearance. Then a syringe containing the study drug was handed directly to the investigator. The study drug code was sealed and not opened until all evaluations had been finalized after the completion of treatment"
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 in the efficacy analysis
Incomplete outcome data (attrition bias) Objective outcomes (including mortality and safety data)	Low risk	Comment: adverse events were recorded for all participants
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