Tanioka 2013.

Study characteristics
Methods	Randomised, placebo‐controlled, phase 2 study with 2 arms comparison of aprepitant + granisetron + dexamethasone vs placebo + granisetron + dexamethasone Study period: January 2011 to September 2012 94 patients enrolled and randomised Masking: double‐blind Baseline patient characteristics: reported Follow‐up: n.r.
Participants	Inclusion criteria women aged 20 to 69 years with histologically confirmed malignancy who were naïve to aprepitant and scheduled to receive carboplatin‐ or irinotecan‐based regimens Eastern Cooperative Oncology Group PS of 0 to 2 estimated life expectancy ≥ 3 months had to meet the following laboratory criteria: neutrophil count ≥ 1500 mm‐3; platelet count ≥ 100,000 mm‐3; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN at the facility; total bilirubin ≤ 1.5 times ULN at the facility; creatinine ≤ 1.5 times ULN at the facility Exclusion criteria history of alcohol consumption, defined as ≥ 1 alcoholic drinks per week at risk of vomiting for other reasons (symptomatic brain metastasis, meningeal infiltration, epilepsy, active peptic ulcer, gastrointestinal obstruction, concomitant abdominal or pelvic radiotherapy) pregnant, nursing, or possibly pregnant women Median age, years: 53 (36 to 67) in aprepitant group, 59 (33 to 69) in placebo group Gender: female Tumour/cancer type: ovarian cancer (early/advanced), endometrial cancer, other, ascites or peritoneal dissemination Chemotherapy regimen: carboplatin + intravenous cytotoxic anti‐tumour drugs such as paclitaxel and pemetrexed; carboplatin + paclitaxel; carboplatin + liposomal doxorubicin; irinotecan + fluorouracil, bevacizumab, or cetuximab Country: Japan (multi‐centre)
Interventions	Experimental: arm A: aprepitant Day 1: aprepitant 125 mg p.o. + granisetron 1 mg i.v. + dexamethasone 12 mg i.v. Days 2 to 3: aprepitant 80 mg p.o. + dexamethasone 4 mg i.v. Experimental: arm B: placebo Day 1: placebo 0 mg p.o. + granisetron 1 mg i.v. + dexamethasone 20 mg i.v. Days 2 to 3: placebo 0 mg p.o. + dexamethasone 8 mg i.v.
Outcomes	Primary endpoint rate of complete response for 120 h from start of first cycle of MEC, in acute (0 to 24 h), delayed (24 to 120 h), and overall (0 to 120 h) phases Secondary endpoint(s) no emesis no rescue therapy no significant nausea no nausea total control (no emesis, no rescue therapy, and no nausea)
Notes	this study has been registered in the University Medical Information Network Clinical Trials Registry as No. 000004998 "the study protocol was funded by the Hanshin Oncology Study Group" conflicts of interest: "HM reported having accepted an unrestricted research grant and received honoraria from Ono Pharmaceutical Co., Ltd. The other authors declare no conflict of interest"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "... randomly assigned to the aprepitant group or placebo group according to a computer‐generated, blinded allocation schedule"
Allocation concealment (selection bias)	Unclear risk	Comment: precise 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
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes)	Low risk	Quote: "of these, 91 patients were included in the full analysis set"
Incomplete outcome data (attrition bias) Objective outcomes (including mortality and safety data)	Low risk	Quote: "safety was evaluated in all the 92 subjects who were assigned to treatment, including the patient who discontinued chemotherapy due to a hypersensitivity reaction"
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