Ziegler 1972a.
Methods | Randomised, parallel group, single‐site trial (Uganda). Method of randomisation: unclear. Allocation concealment: unclear. ITT: no. Withdrawals: stated. | |
Participants | Baseline characteristics: sample size: 41 participants, 27 were evaluable for the study.
Age range: 3 to 25 years.
Tumour staging: Ziegler.
Diagnosis: histopathology. Entry criteria: stages III or IV disease, untreated, histopathologic diagnosis. Exclusion criteria: not stated. |
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Interventions | Multiple doses of C versus the TRIKE regimen (sequential regimen using C, O, MTX and Ara‐C). Follow‐up: participants followed up until death. |
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Outcomes | Relapse. Remission. Overall survival. | |
Notes | 2:1 allocation was used in randomisation. Full text publication. Randomisation rating: B. Withdrawal bias rating: C. Study type: remission induction. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised by stage". |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Nature and frequency of relapse was reported |
AD: adriamycin (doxorubicin) Ara‐C: cytosine arabinoside BCG: Bacille‐Calmette‐Guerin BL: Burkitt lymphoma BLL: Burkitt‐like lymphoma C: cyclophosphamide CNS: central nervous system COM: cyclophosphamide, oncovin and methotrexate COMP: cyclophosphamide, oncovin, methotrexate and prednisolone Gy: Gray unit (SI unit of absorbed radiation) HYD: hydrocortisone IT: intrathecal ITT: intention‐to‐treat analysis IV: intravenous MTX: methotrexate NHL: non‐Hodgkin's lymphoma O: oncovin (vincristine) P: prednisolone SNCCL: small non‐cleaved cell lymphoma TF: transfer factor