Bubalo 2018.

Study characteristics
Methods	Randomised, prospective, placebo‐controlled, parallel, pilot study with 2 arms comparison of aprepitant 125/80 mg + ondansetron + dexamethasone vs placebo + ondansetron + dexamethasone Recruitment period: n.r. 40 patients enrolled and randomised Masking: double‐blind Baseline patient characteristics: reported Follow‐up: n.r.
Participants	Inclusion criteria 18 years of age or older scheduled for an autologous or allogeneic bone marrow or peripheral blood stem cell transplant Eastern Cooperative Oncology Group performance status ≤ 2 able to swallow tablets and capsules received myeloablative CY/TBI or targeted busulfan (TBu)/CY as the conditioning regimen Exclusion criteria sensitivity to aprepitant, ondansetron, or dexamethasone received another investigational drug within the past 30 days had emesis or required antiemetic agents in the 48 h before beginning conditioning therapy had taken an NK₁ antagonist in the 14 days before enrolment pregnant, positive serum hCG, or lactating serum creatinine level ≥ 2 × ULN severe hepatic insufficiency (Child‐Pugh score > 9) drank > 5 alcoholic drinks/d over the last year concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy Mean age (range), years: 46 (19 to 60) in aprepitant group, 46 (19 to 63) in placebo group Gender: male (28) + female (12) Tumour/cancer type: acute lymphoblastic leukemia, acute myelogenous leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, non‐Hodgkin lymphoma, myelodysplastic syndrome, myelofibrosis, Waldenstrom’s macroglobulinemia Chemotherapy regimen: very high doses of cyclophosphamide Country: United States (single centre)
Interventions	Experimental: arm A: aprepitant aprepitant 125 mg on Day 1 and 80 mg through Day +4 + ondansetron given per institutional guidelines on each day of chemotherapy or radiation as described in appendix A + dexamethasone 12 mg p.o. for 1 dose given on Day 1, and 8 mg p.o. once daily given on subsequent days Experimental: arm B: placebo placebo + ondansetron + dexamethasone
Outcomes	Primay objective to determine if there was a difference in the number of emesis‐free days among patients who received aprepitant as compared to those who received placebo from the first day of conditioning to Day +4 Secondary objectives to assess the safety of aprepitant in the HSCT population, as well as to evaluate if there was a difference in the incidence of nausea, mucositis, appetite, and dysgeusia between the 2 study groups
Notes	"Joseph Bubalo is on the Merck and Co., Speakers Bureau and also received clinical trial support as a grant from Merck and Co." "this work is partly funded by Merck & Co., Inc."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "a randomization list was generated using a permuted block randomization with a random block size of either 2 or 4"
Allocation concealment (selection bias)	Unclear risk	Comment: allocation concealment not reported
Blinding of participants and personnel (performance bias) Blinding of participants	Low risk	Quote: "the medications were administered on the same schedule to effectively blind the patients and healthcare staff"
Blinding of participants and personnel (performance bias) Blinding of personnel	Low risk	Quote: "the medications were administered on the same schedule to effectively blind the patients and healthcare staff"
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	Comment: all patients were included in the efficacy analysis
Incomplete outcome data (attrition bias) Objective outcomes (including mortality and safety data)	Low risk	Comment: all patients were included in the safety analysis
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