Bubalo 2005.

Study characteristics
Methods	Randomised, parallel‐group, controlled trial with 2 arms comparison of aprepitant 125/80 mg + ondansetron + dexamethasone vs placebo + ondansetron + dexamethasone Study period: May 2004 to January 2009 40 patients enrolled and randomised Masking: quadruple‐blind (participant, care provider, investigator, outcomes assessor) 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 stem cell transplant Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 must have signed informed consent must be able to swallow tablets and capsules must be receiving a cyclophosphamide‐containing regimen Exclusion criteria known sensitivity to aprepitant, ondansetron, or dexamethasone has received another investigational drug in the past 30 days has had emesis or requires antiemetic agents in the 48 h before beginning conditioning therapy has taken neurokinin₁ antagonists for 14 days before enrolment pregnant, positive serum human chorionic gonadotropin (hCg), or lactating serum creatinine level ≥ 2 × ULN severe hepatic insufficiency (Child‐Pugh score > 9) has been drinking > 5 drinks/d over the last year concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy Mean age (range), years: 46 ± 12.9 in aprepitant group, 46 ± 13 in placebo group Gender: male (28) + female (12) Tumour/cancer type: n.r. Chemotherapy regimen: cyclophosphamide‐containing regimen before transplant Country: United States (single centre)
Interventions	Experimental: arm A: aprepitant aprepitant: loading dose of 125‐mg capsule once a day for 1 day, then maintenance dose of 80‐mg capsule daily through Day +4 of bone marrow transplant dexamethasone: for cyclophosphamide total body irradiation (CyTBI) patients: dexamethasone study drug 1 capsule p.o. daily, 1 h before chemotherapy, with aprepitant on total body irradiation (TBI) and cyclophosphamide chemotherapy days; for busulfan cyclophosphamide (BuCy) patients: dexamethasone 1 capsule orally once daily, discontinued after last dose of chemotherapy ondansetron: for CyTBI patients: ondansetron 8 mg orally every 12 h, beginning 1 h before first TBI dose and discontinued after last dose; then ondansetron 8 mg i.v. every 12 h × 4 doses, beginning 30 min before first cyclophosphamide chemotherapy; for BuCy patients: ondansetron 8 mg p.o. every 6 h, beginning 1 h before first busulfan dose and discontinued after last busulfan dose is given; then ondansetron 8 mg i.v. every 12 h × 4 doses, beginning 30 min before first cyclophosphamide chemotherapy Experimental: arm B: placebo placebo comparator: sugar pill: loading dose of 125‐mg capsule once a day for 1 day, then maintenance dose of 80‐mg capsule daily through Day +4 of bone marrow transplant dexamethasone and ondansetron: same doses and routine as arm A
Outcomes	Primary outcome measures number of emesis‐free participants during the study period [Time frame: up to 3 weeks] Secondary outcome measures safety in transplant population [Time frame: up to 3 weeks] effects on nausea, appetite, and taste changes [Time frame: up to 3 weeks] pharmacokinetic interaction [Time frame: up to 3 weeks]
Notes	sponsors and collaborators: OHSU Knight Cancer Institute clinicalTrials.gov Identifier: NCT00248547 results from study registry
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	Low risk	Comment: NCT00248547 reported that masking was quadruple (participant, care provider, investigator, outcomes assessor)
Blinding of participants and personnel (performance bias) Blinding of personnel	Low risk	Comment: NCT00248547 reported that masking was quadruple (participant, care provider, investigator, outcomes assessor)
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
Incomplete outcome data (attrition bias) Subjective outcomes (Patient reported outcomes)	Low risk	Comment: all randomised patients were assessed for the primary outcome
Selective reporting (reporting bias)	High risk	Comment: primary outcome reported; "effects on nausea, appetite and taste changes" and "pharmacokinetic interaction" are missing
Other bias	Low risk	Comment: no information to suggest other sources of bias