Study |
Randomisation |
Method randomisation |
Concealed allocation |
Intention‐to‐treat |
De Souza |
Yes |
Computer random‐number tables, balanced blocks |
Yes (centrally) |
Yes (54/54) |
Martelli 2003 |
Yes |
Random number tables, restriction to randomisation: none |
Yes (centrally) |
Yes (150/150) |
Gianni |
Yes |
Stratification according to presence or absence of bulky disease and the number of sites of extranodal disease, nothing else stated |
not reported |
101 patients randomised, 98 patients analysed (exclusion due to concomitant liver disease) |
Gisselbrecht |
Yes |
Random number tables, balanced blocks, stratification according to centres |
Yes (centrally) |
397 patients randomised, 370 patients analysed; 27 patients excluded from the analysis due to ineligibility (15x incorrect histology, 1x Burkitt with bone marrow involvement, 1x HIV, 10x missing data) |
Haioun |
Yes |
Generation by the GELA Coordinating Center, stratification according to centres |
Assignement by the GELA Coordinating Center, allocation by telephone |
Yes (541/541) |
Intragumtornchai |
Yes |
Computer random number generator, stratification according to age and tumour response, blocks (size 3 and 4) |
Yes (sealed envelopes in each center) |
Yes (48/48) |
Kaiser |
Yes |
Computer random number generator, stratification according age, LDH and stage |
Yes (centrally) |
331 patients randomised, 312 patients analysed (19 patients excluded from the analysis due to violation of entry criteria) |
Kluin‐Nelemans |
Yes |
Computer random number generator, minimization with stratification |
Yes (centrally) |
Yes (194/194) |
Martelli 1996 |
Yes |
Computer random‐number generator, restriction to randomisation: none |
Yes (centrally) |
Yes (49/49) |
Milpied |
Yes |
Random number tables, no restriction |
Sealed envelopes |
Yes (197/197) |
Rodriguez 2003 |
Yes |
not reported |
not reported |
116 patients randomised, 108 patients analysed |
Santini 1998 |
Yes |
Random number tables, balanced blocks (size 4 and 6) |
Yes (centrally) |
Yes (124/124) |
Santini 2003 |
Yes |
Randomisation was carried out by telephone |
unclear |
Yes |
Verdonck |
Yes |
Random number tables, stratification for institution, balanced blocks (size 4) |
Yes (centrally) |
in paper: 69/73 patients analysed, in provided data 73/73 patients |
Vitolo |
Yes |
Computer random‐number tables, stratification |
Yes (centrally) |
130 patients randomised, 126 analysed (4 patients excluded due to major violations) |