Fox‐Geiman 2001.
Study characteristics | ||
Methods |
Randomised, comparative trial with 3 arms
Recruitment period: September 1997 to September 1998
Masking: double‐blind Baseline patient characteristics: reported Follow‐up: n.r. |
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Participants |
Inclusion criteria
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) |
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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) |
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Outcomes |
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Notes |
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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 |