| 1.1 Clinical heart failure available‐case |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.1.1 Adults |
7 |
1221 |
Risk Ratio (M‐H, Random, 95% CI) |
0.22 [0.11, 0.43] |
| 1.1.2 Children |
3 |
885 |
Risk Ratio (M‐H, Random, 95% CI) |
0.20 [0.01, 4.19] |
| 1.2 Clinical heart failure best‐case |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.2.1 Adults |
7 |
1249 |
Risk Ratio (M‐H, Random, 95% CI) |
0.22 [0.11, 0.43] |
| 1.2.2 Children |
3 |
959 |
Risk Ratio (M‐H, Random, 95% CI) |
0.20 [0.01, 4.19] |
| 1.3 Clinical heart failure worst‐case |
10 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.3.1 Adults |
7 |
1249 |
Risk Ratio (M‐H, Random, 95% CI) |
0.42 [0.21, 0.84] |
| 1.3.2 Children |
3 |
959 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.68, 1.43] |
| 1.4 Cardiomyopathy/heart failure primary cause of death available‐case (best‐case and worst‐case identical results) |
3 |
1008 |
Risk Ratio (M‐H, Random, 95% CI) |
Not estimable |
| 1.4.1 Children |
3 |
1008 |
Risk Ratio (M‐H, Random, 95% CI) |
Not estimable |
| 1.5 Heart failure (i.e. clinical heart failure and subclinical myocardial dysfunction combined) available‐case |
6 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.5.1 Adults (comparable definition 1) |
3 |
417 |
Risk Ratio (M‐H, Random, 95% CI) |
0.37 [0.24, 0.56] |
| 1.5.2 Adults (comparable definition 2) |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.46 [0.33, 0.66] |
| 1.5.3 Children (comparable definition 1) |
1 |
33 |
Risk Ratio (M‐H, Random, 95% CI) |
0.33 [0.13, 0.85] |
| 1.6 Heart failure (i.e. clinical heart failure and subclinical myocardial dysfunction combined) best‐case |
7 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.6.1 Adults (comparable definition 1) |
4 |
605 |
Risk Ratio (M‐H, Random, 95% CI) |
0.29 [0.19, 0.44] |
| 1.6.2 Adults (comparable definition 2) |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.46 [0.33, 0.66] |
| 1.6.3 Children (comparable definition 1) |
1 |
38 |
Risk Ratio (M‐H, Random, 95% CI) |
0.36 [0.14, 0.95] |
| 1.7 Heart failure (i.e. clinical heart failure and subclinical myocardial dysfunction combined) worst‐case |
6 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.7.1 Adults (comparable definition 1) |
3 |
455 |
Risk Ratio (M‐H, Random, 95% CI) |
0.60 [0.42, 0.86] |
| 1.7.2 Adults (comparable definition 2) |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.46 [0.33, 0.66] |
| 1.7.3 Children (comparable definition 1) |
1 |
38 |
Risk Ratio (M‐H, Random, 95% CI) |
0.42 [0.20, 0.86] |
| 1.8 Overall survival |
4 |
|
Hazard Ratio (IV, Random, 95% CI) |
Subtotals only |
| 1.8.1 Adults |
4 |
|
Hazard Ratio (IV, Random, 95% CI) |
1.04 [0.88, 1.23] |
| 1.9 Overall mortality |
3 |
|
Hazard Ratio (IV, Random, 95% CI) |
1.01 [0.72, 1.42] |
| 1.9.1 Children |
3 |
|
Hazard Ratio (IV, Random, 95% CI) |
1.01 [0.72, 1.42] |
| 1.10 Progression‐free survival |
4 |
|
Hazard Ratio (IV, Random, 95% CI) |
Subtotals only |
| 1.10.1 Adults (PFS defined as time from first date of complete response, partial response or stable disease until the date progressive disease was first noticed) |
1 |
|
Hazard Ratio (IV, Random, 95% CI) |
0.62 [0.43, 0.90] |
| 1.10.2 Adults (PFS defined as time to progression; starting point nm) |
1 |
|
Hazard Ratio (IV, Random, 95% CI) |
0.95 [0.64, 1.40] |
| 1.10.3 Adults (PFS defined as time from randomisation to progression either on or off treatment) |
2 |
|
Hazard Ratio (IV, Random, 95% CI) |
1.18 [0.97, 1.43] |
| 1.11 Response rate available‐case |
7 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.11.1 Adults |
6 |
956 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.79, 1.04] |
| 1.11.2 Children (complete response defined as disappearance of active Hodgkin lymphoma (gallium negative, ≥ 70% decrease in the sum of the products of the perpendicular diameters of measurable lesions, and negative bone marrow or bone scan if initially positive)) |
1 |
200 |
Risk Ratio (M‐H, Random, 95% CI) |
0.92 [0.84, 1.01] |
| 1.12 Response rate best‐case |
8 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.12.1 Adults |
6 |
1021 |
Risk Ratio (M‐H, Random, 95% CI) |
0.94 [0.82, 1.08] |
| 1.12.2 Children (complete response defined as disappearance of active Hodgkin lymphoma (gallium negative, ≥ 70% decrease in the sum of the products of the perpendicular diameters of measurable lesions, and negative bone marrow or bone scan if initially positive)) |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
0.92 [0.84, 1.00] |
| 1.12.3 Children (no definition of complete remission provided) |
1 |
206 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.95, 1.07] |
| 1.13 Response rate worst‐case |
7 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.13.1 Adults |
6 |
1021 |
Risk Ratio (M‐H, Random, 95% CI) |
0.89 [0.78, 1.01] |
| 1.13.2 Children (complete response defined as disappearance of active Hodgkin lymphoma (gallium negative, ≥ 70% decrease in the sum of the products of the perpendicular diameters of measurable lesions, and negative bone marrow or bone scan if initially positive)) |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.85, 1.07] |
| 1.14 Adverse effects: Secondary malignant neoplasms (Children) |
4 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.14.1 Secondary malignant neoplasms available‐case |
3 |
1015 |
Risk Ratio (M‐H, Random, 95% CI) |
3.08 [1.13, 8.38] |
| 1.14.2 Secondary malignant neoplasms best‐case |
4 |
1220 |
Risk Ratio (M‐H, Random, 95% CI) |
2.51 [0.96, 6.53] |
| 1.14.3 Secondary malignant neoplasms worst‐case |
3 |
1015 |
Risk Ratio (M‐H, Random, 95% CI) |
3.08 [1.13, 8.38] |
| 1.15 Adverse effects: Haematological effects (Adults) |
6 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.15.1 Thrombocytopenia grade 3 or 4 (WHO/CTCAEv2 criteria)available‐case |
3 |
452 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.48, 2.20] |
| 1.15.2 Thrombocytopenia grade 3 or 4 (WHO/CTCAEv2 criteria) best‐case |
3 |
455 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.47, 2.17] |
| 1.15.3 Thrombocytopenia grade 3 or 4 (WHO/CTCAEv2 criteria) worst‐case |
3 |
455 |
Risk Ratio (M‐H, Random, 95% CI) |
1.20 [0.58, 2.46] |
| 1.15.4 Neutropenia grade 3 or 4 (WHO/CTCAEv2 criteria) available‐case |
2 |
292 |
Risk Ratio (M‐H, Random, 95% CI) |
1.05 [0.96, 1.15] |
| 1.15.5 Neutropenia grade 3 or 4 (WHO/CTCAEv2 criteria) best‐case |
2 |
293 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.94, 1.14] |
| 1.15.6 Neutropenia grade 3 or 4 (WHO/CTCAEv2 criteria) worst‐case |
2 |
293 |
Risk Ratio (M‐H, Random, 95% CI) |
1.05 [0.96, 1.15] |
| 1.15.7 Abnormal granulocyte count at nadir grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.96, 1.13] |
| 1.15.8 Abnormal granulocyte count at recovery grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.85 [0.59, 1.21] |
| 1.15.9 Abnormal white blood cell count at nadir grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
1.16 [1.05, 1.29] |
| 1.15.10 Abnormal white blood cell count at recovery grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.36, 1.31] |
| 1.15.11 Abnormal platelet count at nadir grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.42, 1.84] |
| 1.15.12 Abnormal platelet count at recovery grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.84 [0.16, 4.42] |
| 1.15.13 Anaemia grade 3 or 4 (WHO/CTCAEv2 criteria) available‐case |
3 |
452 |
Risk Ratio (M‐H, Random, 95% CI) |
1.37 [0.79, 2.39] |
| 1.15.14 Anaemia grade 3 or 4 (WHO/CTCAEv2 criteria) best‐case |
3 |
455 |
Risk Ratio (M‐H, Random, 95% CI) |
1.36 [0.78, 2.35] |
| 1.15.15 Anaemia grade 3 or 4 (WHO/CTCAEv2 criteria) worst‐case |
3 |
455 |
Risk Ratio (M‐H, Random, 95% CI) |
1.50 [0.82, 2.73] |
| 1.15.16 Severe myelosuppresion (no definition provided) available‐case |
1 |
108 |
Risk Ratio (M‐H, Random, 95% CI) |
2.00 [0.19, 21.41] |
| 1.15.17 Severe myelosuppresion (no definition provided) best‐case |
1 |
110 |
Risk Ratio (M‐H, Random, 95% CI) |
2.00 [0.19, 21.42] |
| 1.15.18 Severe myelosuppresion (no definition provided) worst‐case |
1 |
110 |
Risk Ratio (M‐H, Random, 95% CI) |
1.50 [0.26, 8.63] |
| 1.15.19 Leukopenia grade 3 or 4 (WHO/CTCAEv2 criteria) available‐case |
2 |
324 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.66, 1.83] |
| 1.15.20 Leukopenia grade 3 or 4 (WHO/CTCAEv2 criteria) best‐case |
2 |
326 |
Risk Ratio (M‐H, Random, 95% CI) |
1.09 [0.66, 1.82] |
| 1.15.21 Leukopenia grade 3 or 4 (WHO/CTCAEv2 criteria) worst‐case |
2 |
326 |
Risk Ratio (M‐H, Random, 95% CI) |
1.17 [0.71, 1.93] |
| 1.16 Adverse effects: Haematological effects (Children) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.16.1 Lymphocytes (no definition provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.07, 16.37] |
| 1.16.2 Lymphocytes (no definition provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.06, 15.94] |
| 1.16.3 Lymphocytes (no definition provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.20 [0.65, 2.22] |
| 1.16.4 Haemoglobin grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
1.48 [1.13, 1.95] |
| 1.16.5 Haemoglobin grade (no definition provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
2.96 [1.31, 6.72] |
| 1.16.6 Haemoglobin grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
1.48 [1.12, 1.95] |
| 1.16.7 Haemoglobin grade (no definition provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
2.88 [1.26, 6.57] |
| 1.16.8 Haemoglobin grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
1.47 [1.12, 1.93] |
| 1.16.9 Haemoglobin grade (no definition provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.74 [1.09, 2.77] |
| 1.16.10 White blood cell count (no definition provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
1.87 [1.30, 2.68] |
| 1.16.11 White blood cell count (no definition provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.81 [1.25, 2.63] |
| 1.16.12 White blood cell count (no definition provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.61 [1.22, 2.13] |
| 1.16.13 Thrombosis grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
4.08 [0.46, 35.87] |
| 1.16.14 Thrombosis grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
4.07 [0.46, 35.87] |
| 1.16.15 Thrombosis grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
2.55 [0.51, 12.84] |
| 1.16.16 Platelets grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
2.45 [1.79, 3.35] |
| 1.16.17 Platelets grade (no definition provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
1.87 [0.90, 3.86] |
| 1.16.18 Platelets grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
2.45 [1.79, 3.36] |
| 1.16.19 Platelets (no definition provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.81 [0.87, 3.78] |
| 1.16.20 Platelets grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
2.41 [1.77, 3.27] |
| 1.16.21 Platelets (no definition provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.45 [0.93, 2.27] |
| 1.16.22 Absolute neutrophil count grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [1.00, 1.20] |
| 1.16.23 Absolute neutrophil count grade (no definition provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
1.27 [1.03, 1.58] |
| 1.16.24 Absolute neutrophil count grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [1.00, 1.20] |
| 1.16.25 Absolute neutrophil count (no definition provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.98, 1.56] |
| 1.16.26 Absolute neutrophil count grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
1.09 [1.00, 1.20] |
| 1.16.27 Absolute neutrophil count (no definition provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.23 [1.03, 1.47] |
| 1.16.28 Hematological effects grade 3 or 4 (NCI CTCAEv2 criteria) available‐case (best‐case and worst‐case identical results) |
1 |
537 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.94, 1.05] |
| 1.17 Adverse effects: Immune system/infectious effects (Adults) |
4 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.17.1 Fever grade 3 or 4 ( ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
1.43 [0.81, 2.54] |
| 1.17.2 Febrile bone marrow aplasia grade 3 or 4 (CTCAEv2 criteria) available‐case (best‐case and worst‐case identical results) |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
3.72 [0.42, 32.55] |
| 1.17.3 Febrile neutropenia grade 3 or 4 (CTCAEv2 criteria) available‐case (best‐case and worst‐case identical results) |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
1.27 [0.62, 2.59] |
| 1.17.4 Fever with positive blood cultures (no reference provided) available‐case (best‐case and worst‐case identical results) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
0.65 [0.11, 3.77] |
| 1.17.5 Fever with other positive cultures (no reference provided) available‐case (best‐case and worst‐case identical results) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
1.95 [0.37, 10.31] |
| 1.18 Adverse effects: Immune system/infectious effects (Children) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.18.1 Sepsis grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
2.04 [0.96, 4.33] |
| 1.18.2 Sepsis (bacteria; further definition not provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.07, 16.37] |
| 1.18.3 Sepsis grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
2.04 [0.96, 4.33] |
| 1.18.4 Sepsis (bacteria; further definition not provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.06, 15.94] |
| 1.18.5 Sepsis grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
1.94 [0.94, 3.97] |
| 1.18.6 Sepsis (bacteria; further definition not provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.20 [0.65, 2.22] |
| 1.18.7 Infection grade 3 or 4 (NCI CTCAEv2 criteria; for Schwartz 2009 explicitly stated not otherwise specified/unknown) available‐case |
2 |
751 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.78, 1.97] |
| 1.18.8 Infection (definition not provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
0.35 [0.04, 3.27] |
| 1.18.9 Infection grade 3 or 4 (NCI CTCAEv2 criteria; for Schwartz 2009 explicitly stated not otherwise specified/unknown) best‐case |
2 |
753 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.78, 1.97] |
| 1.18.10 Infection (definition not provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
0.34 [0.04, 3.19] |
| 1.18.11 Infection grade 3 or 4 (NCI CTCAEv2 criteria; for Schwartz 2009 explicitly stated not otherwise specified/unknown) worst‐case |
2 |
753 |
Risk Ratio (M‐H, Random, 95% CI) |
1.24 [0.79, 1.95] |
| 1.18.12 Infection (definition not provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.59, 1.93] |
| 1.18.13 Allergic reaction grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
3.57 [0.76, 16.78] |
| 1.18.14 Allergic reaction (definition not provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
0.26 [0.03, 2.28] |
| 1.18.15 Allergic reaction grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
3.57 [0.76, 16.78] |
| 1.18.16 Allergic reaction (definition not provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
0.25 [0.03, 2.22] |
| 1.18.17 Allergic reaction grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
2.72 [0.74, 9.97] |
| 1.18.18 Allergic reaction (definition not provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.56, 1.81] |
| 1.19 Adverse effects: Gastrointestinal effects (Adults) |
6 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.19.1 Nausea grade 3 or 4 (CTCAEv2 criteria) available‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.19 [0.02, 1.56] |
| 1.19.2 Nausea grade 3 or 4 (CTCAEv2/ECOG criteria) best‐case |
3 |
698 |
Risk Ratio (M‐H, Random, 95% CI) |
0.70 [0.50, 0.97] |
| 1.19.3 Nausea grade 3 or 4 (CTCAEv2 criteria) worst‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.19 [0.02, 1.56] |
| 1.19.4 Vomiting grade 3 or 4 (CTCAEv2 criteria) available‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.15 [0.02, 1.26] |
| 1.19.5 Vomiting grade 3 or 4 (CTCAEv2/ECOG criteria) best‐case |
3 |
698 |
Risk Ratio (M‐H, Random, 95% CI) |
0.71 [0.37, 1.39] |
| 1.19.6 Vomiting grade 3 or 4 (CTCAEv2 criteria) worst‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.15 [0.02, 1.26] |
| 1.19.7 Nausea and vomiting ‐ controllable (reference not provided) available‐case (best‐case and worst‐case identical results) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
1.07 [0.81, 1.40] |
| 1.19.8 Nausea and vomiting ‐ vomiting intractable (reference not provided) available‐case (best‐case and worst‐case identical results) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
0.39 [0.08, 1.95] |
| 1.19.9 Nausea and vomiting grade 3 or 4 (WHO criteria) available‐case |
1 |
128 |
Risk Ratio (M‐H, Random, 95% CI) |
0.32 [0.09, 1.11] |
| 1.19.10 Nausea and vomiting grade 3 or 4 (WHO criteria) best‐case |
1 |
129 |
Risk Ratio (M‐H, Random, 95% CI) |
0.31 [0.09, 1.09] |
| 1.19.11 Nausea and vomiting grade 3 or 4 (WHO criteria) worst‐case |
1 |
129 |
Risk Ratio (M‐H, Random, 95% CI) |
0.42 [0.14, 1.27] |
| 1.19.12 Stomatitis grade 3 or 4 (WHO criteria) available‐case |
2 |
288 |
Risk Ratio (M‐H, Random, 95% CI) |
0.96 [0.38, 2.44] |
| 1.19.13 Stomatitis grade 3 or 4 (WHO criteria) best‐case |
2 |
291 |
Risk Ratio (M‐H, Random, 95% CI) |
0.94 [0.38, 2.37] |
| 1.19.14 Stomatitis grade 3 or 4 (WHO criteria) worst‐case |
2 |
291 |
Risk Ratio (M‐H, Random, 95% CI) |
1.17 [0.42, 3.24] |
| 1.19.15 Stomatitis grade 3 or 4 (CTCAEv2 criteria) available‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.19 [0.01, 3.82] |
| 1.19.16 Stomatitis grade 3 or 4 (CTCAEv2/ECOG criteria) best‐case |
3 |
698 |
Risk Ratio (M‐H, Random, 95% CI) |
0.70 [0.38, 1.30] |
| 1.19.17 Stomatitis grade 3 or 4 (CTCAEv2 criteria) worst‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.19 [0.01, 3.82] |
| 1.19.18 Stomatitis (ulcers can eat) (no reference provided) available‐case (best‐case and worst‐case identical results) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
0.89 [0.40, 1.96] |
| 1.19.19 Stomatitis (ulcers cannot eat) (no reference provided) available‐case (best‐case and worst‐case identical results) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
0.42 [0.11, 1.55] |
| 1.19.20 Diarrhoea grade 3 or 4 (CTCAEv2 criteria) available‐case (best‐case and worst‐case identical results) |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.06, 14.61] |
| 1.19.21 Diarrhoea grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
1.15 [0.40, 3.30] |
| 1.19.22 Nausea grade 3 or 4 (WHO criteria) available‐case |
1 |
160 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.25, 3.67] |
| 1.19.23 Nausea grade 3 or 4 (WHO criteria) best‐case |
1 |
162 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.24, 3.59] |
| 1.19.24 Nausea grade 3 or 4 (WHO criteria) worst‐case |
1 |
162 |
Risk Ratio (M‐H, Random, 95% CI) |
1.39 [0.41, 4.75] |
| 1.19.25 Vomiting grade 3 or 4 (WHO criteria) available‐case |
1 |
160 |
Risk Ratio (M‐H, Random, 95% CI) |
1.11 [0.39, 3.16] |
| 1.19.26 Vomiting grade 3 or 4 (WHO criteria) best‐case |
1 |
162 |
Risk Ratio (M‐H, Random, 95% CI) |
1.08 [0.38, 3.08] |
| 1.19.27 Vomiting grade 3 or 4 (WHO criteria) worst‐case |
1 |
162 |
Risk Ratio (M‐H, Random, 95% CI) |
1.39 [0.52, 3.73] |
| 1.20 Adverse effects: Gastrointestinal effects (Children) |
3 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.20.1 Nausea (no definition provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
1.04 [0.15, 7.23] |
| 1.20.2 Nausea (no definition provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.14, 7.05] |
| 1.20.3 Nausea (no definition provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.65, 2.16] |
| 1.20.4 Vomiting (no definition provided) available‐case |
1 |
222 |
Risk Ratio (M‐H, Random, 95% CI) |
0.62 [0.15, 2.54] |
| 1.20.5 Vomiting (no definition provided) best‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
0.60 [0.15, 2.48] |
| 1.20.6 Vomiting (no definition provided) worst‐case |
1 |
255 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.60, 1.85] |
| 1.20.7 Nausea or vomiting grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.44, 2.35] |
| 1.20.8 Nausea or vomiting grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.44, 2.35] |
| 1.20.9 Nausea or vomiting grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.46, 2.25] |
| 1.20.10 Stomatitis grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.64, 1.51] |
| 1.20.11 Stomatitis grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.64, 1.51] |
| 1.20.12 Stomatitis grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.65, 1.50] |
| 1.20.13 Mucositis grade 3 or 4 (NCI CTCAEv2 criteria) available‐case (best‐case and worst‐case identical results) |
1 |
537 |
Risk Ratio (M‐H, Random, 95% CI) |
0.61 [0.41, 0.92] |
| 1.20.14 Typhlitis grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
3.06 [0.85, 10.98] |
| 1.20.15 Typhlitis grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
3.06 [0.85, 10.98] |
| 1.20.16 Typhlitis grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
2.55 [0.82, 7.87] |
| 1.21 Adverse effects: Neurological effects (Adults) |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.21.1 Neurotoxicity (ECOG criteria) grade 3 or 4 best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.62 [0.03, 13.45] |
| 1.22 Adverse effects: Neurological (Children) |
2 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.22.1 Central nervous system grade 3 or 4 (NCI CTCAEv2 criteria; for Schwartz 2009 explicitly stated that it includes mood, cortical and cerebellar) available‐case |
2 |
751 |
Risk Ratio (M‐H, Random, 95% CI) |
1.21 [0.72, 2.03] |
| 1.22.2 Central nervous system grade 3 or 4 (NCI CTCAEv2 criteria; for Schwartz 2009 explicitly stated that it includes mood, cortical and cerebellar) best‐case |
2 |
753 |
Risk Ratio (M‐H, Random, 95% CI) |
1.21 [0.72, 2.03] |
| 1.22.3 Central nervous system grade 3 or 4 (NCI CTCAEv2 criteria; for Schwartz 2009 explicitly stated that it includes mood, cortical and cerebellar) worst‐case |
2 |
753 |
Risk Ratio (M‐H, Random, 95% CI) |
1.21 [0.72, 2.02] |
| 1.22.4 Peripheral nervous system grade 3 or 4 (NCI CTCAEv2 criteria) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
0.68 [0.12, 3.98] |
| 1.22.5 Peripheral nervous system grade 3 or 4 (NCI CTCAEv2 criteria) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
0.68 [0.12, 3.98] |
| 1.22.6 Peripheral nervous system grade 3 or 4 (NCI CTCAEv2 criteria) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
0.76 [0.18, 3.33] |
| 1.23 Adverse effects: Other (Adults) |
5 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.23.1 Severe liver damage (no definition provided) available‐case |
1 |
108 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.06, 15.58] |
| 1.23.2 Severe liver damage (no definition provided) best‐case |
1 |
110 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.06, 15.59] |
| 1.23.3 Severe liver damage (no definition provided) worst‐case |
1 |
110 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.15, 6.85] |
| 1.23.4 Pain on injection grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
1.51 [0.34, 6.73] |
| 1.23.5 Phlebitis grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
1.53 [0.34, 6.90] |
| 1.23.6 Anorexia grade 3 or 4 (ECOG criteria) best‐case |
2 |
534 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.57, 1.65] |
| 1.23.7 Alopecia grade 3 or 4 (CTCAEv2 criteria) available‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.64, 2.24] |
| 1.23.8 Alopecia grade 3 or 4 (CTCAEv2/ECOG criteria) best‐case |
3 |
698 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.94, 1.09] |
| 1.23.9 Alopecia grade 3 or 4 (CTCAEv2 criteria) worst‐case |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
1.19 [0.64, 2.24] |
| 1.23.10 Alopecia severe (reference not provided) available‐case (best‐case and worst‐case identical results) |
1 |
150 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.91, 1.13] |
| 1.23.11 Asthenia grade 3 or 4 (CTCAEv2 criteria) available‐case (best‐case and worst‐case identical results) |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.13, 6.44] |
| 1.23.12 Fatigue grade 3 or 4 (CTCAEv2 criteria) available‐case (best‐case and worst‐case identical results) |
1 |
164 |
Risk Ratio (M‐H, Random, 95% CI) |
2.79 [0.30, 26.25] |
| 1.24 Adverse effects: Other (Children) |
1 |
|
Risk Ratio (M‐H, Random, 95% CI) |
Subtotals only |
| 1.24.1 Pulmonary grade 3 or 4 (NCI CTCAEv2 criteria; explicitly stated that it includes diffusion capacity for carbon momoxide, vital capacity, pulmonary/functional and oxygen saturation) available‐case |
1 |
214 |
Risk Ratio (M‐H, Random, 95% CI) |
4.42 [1.30, 15.05] |
| 1.24.2 Pulmonary grade 3 or 4 (NCI CTCAEv2 criteria; explicitly stated that it includes diffusion capacity for carbon momoxide, vital capacity, pulmonary/functional and oxygen saturation) best‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
4.41 [1.29, 15.05] |
| 1.24.3 Pulmonary grade 3 or 4 (NCI CTCAEv2 criteria; explicitly stated that it includes diffusion capacity for carbon momoxide, vital capacity, pulmonary/functional and oxygen saturation) worst‐case |
1 |
216 |
Risk Ratio (M‐H, Random, 95% CI) |
3.57 [1.21, 10.49] |
