Jantunen 1992.
Study characteristics | ||
Methods |
Randomised, prospective, cross‐over study with 2 arms
Enrolment period: n.r.
Masking: open‐label Baseline patient characteristics: reported Follow‐up: yes |
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Participants |
Inclusion criteria
Exclusion criteria
Median age, years: 58.3 in males, 49.5 in females Gender: male (14) + female (33) Tumour/cancer type: solid tumour (breast, lung, melanoma, other) Chemotherapy regimen: non‐cisplatin‐containing chemotherapy (CNF, CMF, CEF, VAC, carboplatin‐containing, DTIC‐containing, epirubicin‐containing, MTX‐5‐FU, MMM) Country: n.r. |
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Interventions |
Cross‐over study Experimental: arm A: ondansetron 8 mg ondansetron + 10 mg dexamethasone (loading dose of ondansetron was followed by 8 mg ondansetron given orally twice at 8‐h intervals) Experimental: arm B: tropisetron 5 mg tropisetron + 10 mg dexamethasone |
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Outcomes | control of vomiting during first 24 h was scored as
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Notes |
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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 | Comment: open‐label |
Blinding of participants and personnel (performance bias) Blinding of personnel | High risk | Comment: 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 | Quote: "thirty‐nine patients were evaluable for cross‐over 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 |