Patte 1991.
Methods | Randomised, parallel group, multicentre trial (Europe). ITT: stated that all were included in the analysis. Withdrawals: stated. | |
Participants | Baseline characteristics: 216 eligible (166 randomised; long duration: 84; short duration: 82).
Age range: 6 months to 17 years.
Tumour staging: Murphy.
Diagnosis: histology, cytology or immunotyping. Entry criteria: Age <17 years, diagnosis of BL, stages III and IV disease. Exclusion criteria: CNS involvement. After 1986, only those with abdominal or head‐neck primary tumours were included. |
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Interventions | The interventions differed mainly by the duration d the number of drugs given at each stage of treatment; a 5‐week short course compared with a long (16‐week) course with additional drugs maintenance chemotherapy. Follow‐up: 18 months. |
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Outcomes | Remission. Relapse. Toxicity. Overall survival. Event‐free survival. | |
Notes | Full text publication. Equivalence trial. Study type: remission induction. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central, balanced block randomisation. |
Allocation concealment (selection bias) | Low risk | Implied from the description of randomisation from a central office. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes were reported. |