Kaushal 2015.

Study characteristics
Methods	Randomised, prospective study with 2 arms comparison of aprepitant + palonosetron + dexamethasone vs ondansetron + dexamethasone Enrolment period: n.r. 60 patients randomised Masking: open‐label Baseline patient characteristics: reported Follow‐up: n.r.
Participants	Inclusion criteria Karnofsky performance status ≥ 70 normal complete haemogram blood biochemistry within normal limits Exclusion criteria distant metastases pregnant or lactating female history of allergy to ondansetron palonosetron or aprepitant; receipt of chemotherapy during 7 days before study drug administration any associated medical condition causing nausea/vomiting (e.g. renal, liver, heart disease) Median age (range): 52 (36 to 70) in PDA group, 51 (34 to 69) in OD group Gender: male (52) + female (8) Tumour/cancer type: head and neck cancer (squamous cell carcinoma of head and neck) Chemotherapy regimen: docetaxel 60 mg/m² intravenously (i.v.), carboplatin 300 mg/m² i.v., and 5‐FU (5‐fluorouracil) 600 mg/m² i.v. Country: India (single centre)
Interventions	Experimental: arm A: aprepitant + palonosetron + dexamethasone (PDA) Day 1: p.o. aprepitant 125 mg + palonosetron 0.25 mg i.v. + dexamethasone 12 mg i.v. Days 2 to 3: capsule aprepitant 80 mg o.d. + tablet dexamethasone 8 mg b.d. Control: arm B: ondansetron + dexamethasone (OD) Day 1: ondansetron 16 mg i.v. + dexamethasone 12 mg i.v. + ondansetron 8 mg b.d. (after chemotherapy) Days 2 to 3: ondansetron 8 mg b.d. + dexamethasone 8 mg b.d.
Outcomes	Primary endpoint complete response during acute (0 to 24 h) and delayed (24 to 120 h) phases after chemotherapy Secondary endpoint(s) complete response over entire (0 to 120 h) period safety
Notes	study was limited by small sample size no information regarding financing and clinical trial registration reported study authors have no conflicts of interest to declare
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)	Unclear risk	Comment: allocation concealment not reported
Blinding of participants and personnel (performance bias) Blinding of participants	High risk	Quote: "... open label ..."
Blinding of participants and personnel (performance bias) Blinding of personnel	High risk	Quote: "... open label ..."
Blinding of outcome assessment (detection bias) Subjective outcomes (Patient reported outcomes)	High risk	Comment: patients and personnel were not blinded towards the intervention and therefore might influence subjective outcomes analysis
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes)	Low risk	Comment: all patients were included in the efficacy analysis
Selective reporting (reporting bias)	High risk	Comment: the result of safety analysis was not reported in the results section
Other bias	Low risk	Comment: no information to suggest other sources of bias