Rummel 2009.
| Methods | Allocation generation: not reported Allocation concealment: not reported Blinding: no ITT: no Number of dropouts: 36/549 Median follow‐up: 28 months | |
| Participants | 549 randomised, 513 evaluable, adult patients
Type of lymphoma: follicular lymphoma, mantle cell lymphoma, other indolent lymphoma
Stage: 96% of patients stage III/IV Previous treatment: no Mean age: 64 years (range 31 to 83 years) |
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| Interventions | Investigational intervention: Bendamustine 90 mg/m2 on days 1 to 2, and rituximab 375 mg/m2 on day 1; every 4 weeks, up to 6 cycles Comparator intervention: Standard CHOP and rituximab 375 mg/m2 on day 1; every 3 weeks, up to 6 cycles |
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| Outcomes | Progression‐free survival Overall survival Event‐free survival. An event was defined by a response less than a partial response, disease progression, relapse or death from any cause Time to next treatment Adverse events |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Of the 549 randomized patients 36 patients were not evaluable: 10 did not receive any study medication, 9 due to withdrawal of consent, 13 due to incorrect diagnosis, and 4 for other reasons." Allocation of non‐evaluable patients is not reported. |
| Selective reporting (reporting bias) | Low risk | Analyses were done as stated in protocol |
| Other bias | Unclear risk | Research funding by Roche Pharma AG Published as an abstract |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded to allocated treatment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |