Fujiwara 2015.
Study characteristics | ||
Methods |
Randomised, prospective, cross‐over, comparative study with 2 arms
Enrolment period: January 2011 to January 2012
Masking: open‐label Baseline patient characteristics: reported Follow‐up: n.r. |
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Participants |
Inclusion criteria
Exclusion criteria
Median age (range), years: 57.5 (36 to 76) Gender: female (38) Tumour/cancer type: gynaecological cancer (endometrial cancer, cervical cancer, ovarian or tubal cancer, double endometrial and ovarian cancer) Chemotherapy regimen: TC regimen (paclitaxel and carboplatin) Country: Japan (single centre) |
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Interventions |
Cross‐over study Experimental: arm A: palonosetron Day 1: aprepitant 125 mg p.o. + palonosetron 0.75 mg i.v. + dexamethasone 20 mg i.v. Days 2 to 3: aprepitant 80 mg p.o. + dexamethasone 4 mg p.o. Experimental: arm B: granisetron Day 1: aprepitant 125 mg p.o. + granisetron 3 mg i.v. + dexamethasone 20 mg i.v. Days 2 to 3: aprepitant 80 mg p.o. + dexamethasone 4 mg p.o. |
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Outcomes |
Primary endpoint
Secondary endpoint(s)
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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 group assignment was performed by simple randomization using a table of random numbers and patients were informed of which group (arm A or B) they were assigned" |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not reported |
Blinding of participants and personnel (performance bias) Blinding of participants | High risk | Quote: "... non‐blinded ..." |
Blinding of participants and personnel (performance bias) Blinding of personnel | High risk | Quote: "... non‐blinded ..." |
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: "the intent‐to‐treat population included 19 patients who received palonosetron on Day 1 (Arm A) and 19 patients who received granisetron on Day 1 (Arm B)" |
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 |