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. 2021 Nov 16;2021(11):CD012775. doi: 10.1002/14651858.CD012775.pub2

Fox‐Geiman 2001.

Study characteristics
Methods Randomised, comparative trial with 3 arms
  • comparison of oral ondansetron + dexamethasone vs oral granisetron + dexamethasone vs intravenous ondansetron + dexamethasone


Recruitment period: September 1997 to September 1998
  • 102 patients randomised


Masking: double‐blind
Baseline patient characteristics: reported
Follow‐up: n.r.
Participants Inclusion criteria
  • > 17 years old with malignant disease

  • consumed < 5 alcoholic drinks per day in the past year

  • scheduled to receive chemotherapy or chemotherapy preparative regimens

  • estimated creatinine clearance ≥ 50 mL/min

  • normal liver function, defined as total bilirubin < 1.5 × ULN and AST < 2 × ULN 


Exclusion criteria: n.r.
Mean age, years: 45 (oral ondansetron), 46 (oral granisetron), 49 (intravenous ondansetron)
Gender: male + female
Tumour/cancer type: n.r.
Chemotherapy regimen: STAMP V, TBI/VP/CY, TANC, Bu/Cy, BEAM, BCNU/VP/CY, ICE, Carboplatin/VP, Carboplatin/MTZ/CY, MMT, Thiotepa/CY, TBI/CY
Country: United States (single centre)
Interventions Experimental: arm A: oral ondansetron
ondansetron 8 mg p.o. (every 8 hours) + dexamethasone 10 mg i.v. (once daily)
Experimental: arm B: oral granisetron
granisetron 1 mg p.o. (every 12 hours each day) + dexamethasone 10 mg i.v. (once daily)
Experimental: arm C: intravenous ondansetron
ondansetron 32 mg i.v. (single daily dose) + dexamethasone 10 mg i.v. (once daily)
Outcomes
  • complete response (no or mild nausea and no rescue antiemetics used) over 8 days

  • major response (1 episode of vomiting or, if no vomiting occurs, moderate nausea with rescue antiemetics allowed)

  • minor response (2 to 4 episodes of vomiting, regardless of nausea or rescue antiemetic use)

  • failure (> 4 episodes of vomiting, regardless of nausea or rescue antiemetic use)

Notes
  • no information regarding clinical trial registration

  • "supported in part by an educational grant from Glaxo‐Wellcome, Inc., Research Triangle Park, NC"

  • study authors did not provide disclosure of potential conflicts of interest

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the randomization scheme was determined by the study’s biostatistician based on a permuted block design (K = 6)"
Allocation concealment (selection bias) Low risk Quote: "the treatment allocation scheme was maintained by the study pharmacist, who assumed responsibility for blinded drug distribution"
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
Incomplete outcome data (attrition bias)
Subjective outcomes (Patient reported outcomes) Low risk Quote: "... the trial was analysed according to intention to‐treat"
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