Yahata 2016.

Study characteristics
Methods	Randomised, placebo‐controlled, parallel‐group trial with 2 arms comparison of aprepitant + granisetron or ondansetron + dexamethasone vs placebo + granisetron or ondansetron + dexamethasone Study period: April 2011 to December 2013 324 patients screened 307 patients randomised Masking: double‐blind Baseline patient characteristics: reported Follow‐up: n.r.
Participants	Inclusion criteria Japanese patients with gynaecological cancer (age range 20 to 80 years) who were treated with TC combination chemotherapy regimen of paclitaxel at a dose of 175 to 180 mg/m² and carboplatin at a dose of 5 to 6 AUC (concentration vs time curve) every 3 weeks Eastern Cooperative Oncology Group performance status 0 to 2 Exclusion criteria severe liver or renal dysfunction (serum aspartate transaminase > 2.5 × ULN), ALT > 2.5 × ULN, bilirubin > 1.5 × ULN, creatinine > 1.5 × ULN) risk of vomiting for other reasons (active peptic ulcer, gastrointestinal obstruction, etc.) history of chemotherapy or radiation vomiting 24 h before administration of TC combination chemotherapy continuing steroid treatment insulin treatment for diabetes mellitus pregnancy Mean age (range), years: 59 (26 to 77) in aprepitant group, 59 (24 to 79) in placebo group Gender: female Tumour/cancer type: gynaecological cancer (ovarian cancer, endometrial cancer, cervical cancer, peritoneal cancer, tubal cancer) Chemotherapy regimen: TC combination chemotherapy (paclitaxel and carboplatin) Country: Japan (9 institutes, multi‐centre)
Interventions	Experimental: arm A: aprepitant Day 1: aprepitant 125 mg p.o. + granisetron/ondansetron ¼ mg + dexamethasone 20 mg i.v. Days 2 to 3: aprepitant 80 mg p.o. Experimental: arm B: placebo Day 1: placebo 0 mg p.o. + granisetron/ondansetron ¼ mg + dexamethasone 20 mg i.v.
Outcomes	Primary endpoint proportion of patients with hypersensitivity reaction (HSR) Secondary endpoint(s) proportions of patients with no vomiting and no significant nausea complete response proportion of patients with no nausea
Notes	"this study is registered in the University Medical Information Network Clinical Trials Registry (No. 000005215)" "this study was supported in part by a grant‐in‐aid for scientific research from the Japan Society for the Promotion of Science (Numbers 24592520 and 24592519)" conflicts of interest: "the authors declare that they have no 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 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
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes)	Low risk	Quote: "efficacy analyses were conducted with the full analysis set, which was defined as all randomized patients who received at least one dose of the study drugs"
Incomplete outcome data (attrition bias) Objective outcomes (including mortality and safety data)	High risk	Quote: "safety was evaluated in all patients taking the study drugs", but "adverse events obviously caused by paclitaxel and/or carboplatin (e.g. alopecia, neutropenia) were excluded, and only toxicities not related to the study drugs were recorded"
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