All patients
Age < 65y (younger) Age > 65y Age > 75y (older) BRAF mutant BRAF wild type ECOG ⩾ 1 ECOG 0 ECOG 1 Gender, female Gender, male LDH > ULN LDH ≤ULN metastasis (brain) NO metastasis (brain) YES metastasis (liver ) PD-L1 < 1% PD-L1 < 5% PD-L1 > 1% PD-L1 > 5% PDL1 (TC0 and IC0 : <1% of TC and IC) PDL1 (TC1/2/3 or IC1/2/3 : ≥1% of TC or IC) previous systemic treatment (%) previous systemic treatment NO (%) Prior anti-CTLA4 benefit NO Prior anti-CTLA4 benefit YES stage III (locally advanced) stage IIIa stage IIIb stage IIIc stage IV (metastatic) stage M0 stage M0/M1A/M1B stage M1A stage M1B stage M1C stage M1C (with brain metastasis)
Top evidence (RCT only, high risk of bias excluded)
Best available evidence (possibly low or very low)
All RCTs
All studies (RCT+OBS)
studies
melanoma (ML), immune chekpoint inhibitors vs. Standard of Care (SoC), meta-analysis of study results Outcome TE 95% CI n k I2 ROB Pub. bias deaths (OS)detailed results A3671009, 2013 0.88 [0.75; 1.04]
CA184-024, 2011 0.72 [0.59; 0.87]
IMspire-150 (BRAF mutant), 2020 0.85 [0.65; 1.12]
KEYNOTE-002 (10 mg/kg), 2015 0.74 [0.57; 0.96]
KEYNOTE-002 (2 mg/kg), 2015 0.86 [0.67; 1.10]
KEYNOTE-022, 2019 0.76 [0.41; 1.40]
0.81 [0.74 ; 0.89 ] A3671009, 2013, CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-022, 2019 6 0% 2,510 moderate not evaluable deaths (OS) (extension)detailed results CA184-024, 2011 0.69 [0.57; 0.84]
0.69 [0.57 ; 0.84 ] CA184-024, 2011 1 0% NA not evaluable progression or deaths (PFS)detailed results CA184-024, 2011 0.76 [0.63; 0.92]
IMspire-150 (BRAF mutant), 2020 0.78 [0.63; 0.97]
KEYNOTE-002 (10 mg/kg), 2015 0.50 [0.39; 0.64]
KEYNOTE-002 (2 mg/kg), 2015 0.57 [0.45; 0.73]
KEYNOTE-022, 2019 0.66 [0.40; 1.08]
0.65 [0.54 ; 0.78 ] CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-022, 2019 5 62% 1,855 low not evaluable DCRdetailed results CA184-024, 2011 1.15 [0.79; 1.68]
1.15 [0.79 ; 1.68 ] CA184-024, 2011 1 0% 502 NA not evaluable DORdetailed results KEYNOTE-022, 2019 0.41 [0.20; 0.83]
0.41 [0.20 ; 0.83 ] KEYNOTE-022, 2019 1 0% 81 NA not evaluable objective responses (ORR)detailed results A3671009, 2013 1.14 [0.69; 1.88]
CA184-024, 2011 1.56 [0.91; 2.65]
IMspire-150 (BRAF mutant), 2020 1.19 [0.83; 1.71]
KEYNOTE-002 (10 mg/kg), 2015 8.16 [3.74; 17.80]
KEYNOTE-002 (2 mg/kg), 2015 6.11 [2.77; 13.47]
KEYNOTE-022, 2019 0.68 [0.32; 1.47]
1.96 [1.03 ; 3.72 ] A3671009, 2013, CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-022, 2019 6 86% 2,510 low not evaluable AE (any grade)detailed results A3671009, 2013 2.22 [1.12; 4.38]
CA184-024, 2011 5.17 [1.48; 18.09]
KEYNOTE-022, 2019 2.03 [0.18; 23.06]
2.65 [1.48 ; 4.73 ] A3671009, 2013, CA184-024, 2011, KEYNOTE-022, 2019 3 0% 1,262 moderate not evaluable AE (grade 3-4)detailed results A3671009, 2013 1.84 [1.35; 2.52]
CA184-024, 2011 3.39 [2.34; 4.94]
KEYNOTE-022, 2019 2.44 [1.17; 5.12]
2.46 [1.59 ; 3.82 ] A3671009, 2013, CA184-024, 2011, KEYNOTE-022, 2019 3 67% 1,262 low not evaluable AE leading to death (grade 5)detailed results A3671009, 2013 1.71 [0.85; 3.45]
CA184-024, 2011 1.02 [0.02; 51.42]
IMspire-150 (BRAF mutant), 2020 1.23 [0.42; 3.56]
KEYNOTE-022, 2019 4.10 [0.18; 92.93]
1.58 [0.89 ; 2.80 ] A3671009, 2013, CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-022, 2019 4 0% 1,773 moderate not evaluable AE leading to treatment discontinuation (any grade)detailed results A3671009, 2013 97.13 [5.95; 1585.40]
IMspire-150 (BRAF mutant), 2020 0.78 [0.47; 1.29]
KEYNOTE-022, 2019 2.58 [1.16; 5.75]
3.05 [0.63 ; 14.86 ] A3671009, 2013, IMspire-150 (BRAF mutant), 2020, KEYNOTE-022, 2019 3 87% 1,275 low not evaluable SAE (any grade)detailed results A3671009, 2013 3.19 [2.19; 4.65]
3.19 [2.19 ; 4.65 ] A3671009, 2013 1 0% 644 NA not evaluable STRAE (any grade)detailed results IMspire-150 (BRAF mutant), 2020 1.24 [0.85; 1.81]
1.24 [0.85 ; 1.81 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable TRAE (any grade)detailed results CA184-024, 2011 5.64 [3.80; 8.35]
IMspire-150 (BRAF mutant), 2020 0.82 [0.11; 5.85]
KEYNOTE-002 (10 mg/kg), 2015 0.76 [0.45; 1.26]
KEYNOTE-002 (2 mg/kg), 2015 0.56 [0.34; 0.93]
KEYNOTE-022, 2019 1.36 [0.29; 6.34]
1.26 [0.38 ; 4.14 ] CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-022, 2019 5 94% 1,828 low not evaluable TRAE (grade 3-4)detailed results CA184-024, 2011 11.25 [6.30; 20.10]
IMspire-150 (BRAF mutant), 2020 1.41 [0.93; 2.12]
KEYNOTE-002 (10 mg/kg), 2015 0.54 [0.32; 0.91]
KEYNOTE-002 (2 mg/kg), 2015 0.44 [0.25; 0.76]
KEYNOTE-022, 2019 3.60 [1.67; 7.74]
1.66 [0.54 ; 5.14 ] CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-022, 2019 5 95% 1,828 low not evaluable TRAE leading to death (grade 5)detailed results A3671009, 2013 7.00 [0.86; 57.23]
KEYNOTE-002 (10 mg/kg), 2015 1.92 [0.06; 57.48]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
KEYNOTE-022, 2019 2.02 [0.07; 61.28]
3.31 [0.76 ; 14.36 ] A3671009, 2013, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-022, 2019 4 0% 1,463 moderate not evaluable TRAE leading to discontinuation (any grade)detailed results KEYNOTE-002 (10 mg/kg), 2015 1.65 [0.70; 3.87]
KEYNOTE-002 (2 mg/kg), 2015 0.85 [0.32; 2.25]
KEYNOTE-022, 2019 2.67 [1.18; 6.03]
1.62 [0.86 ; 3.05 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015, KEYNOTE-022, 2019 3 36% 819 moderate not evaluable TRAE leading to discontinuation (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 2.73 [0.85; 8.76]
KEYNOTE-002 (2 mg/kg), 2015 1.46 [0.40; 5.25]
2.06 [0.87 ; 4.87 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Adrenal insufficiency TRAE (grade 3-4)detailed results A3671009, 2013 5.93 [0.30; 118.96]
5.93 [0.30 ; 118.96 ] A3671009, 2013 1 0% 644 NA not evaluable Alopecia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
0.96 [0.06 ; 15.38 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Anaemia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.05 [0.00; 0.88]
KEYNOTE-002 (2 mg/kg), 2015 0.10 [0.01; 0.81]
0.08 [0.01 ; 0.43 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Arthralgia TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 1.44 [0.48; 4.34]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.06; 15.39]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.06; 15.48]
1.30 [0.50 ; 3.42 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 low not evaluable Asthenia TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 2.47 [0.45; 13.60]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.06; 15.39]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.06; 15.48]
1.64 [0.45 ; 5.96 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 low not evaluable Blood creatinine increased TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 0.61 [0.02; 18.27]
0.61 [0.02 ; 18.27 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable Chorioretinopathy TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 0.61 [0.02; 18.27]
0.61 [0.02 ; 18.27 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable Colitis TRAE (grade 3-4)detailed results CA184-024, 2011 10.35 [0.56; 190.49]
KEYNOTE-002 (10 mg/kg), 2015 2.90 [0.30; 28.13]
KEYNOTE-002 (2 mg/kg), 2015 0.48 [0.02; 14.37]
2.86 [0.59 ; 13.95 ] CA184-024, 2011, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,197 moderate not evaluable Constipation TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
0.96 [0.06 ; 15.38 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Decreased appetite TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 0.30 [0.01; 6.77]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
0.58 [0.07 ; 4.55 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 moderate not evaluable Diarrhoea TRAE (grade 3-4)detailed results CA184-024, 2011 21.14 [1.23; 363.94]
IMspire-150 (BRAF mutant), 2020 0.53 [0.16; 1.76]
KEYNOTE-002 (10 mg/kg), 2015 1.28 [0.28; 5.81]
KEYNOTE-002 (2 mg/kg), 2015 0.16 [0.01; 3.17]
1.08 [0.25 ; 4.71 ] CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 4 57% 1,708 low not evaluable Dry skin TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 4.92 [0.22; 109.67]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
1.98 [0.25 ; 15.69 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 moderate not evaluable Erythema TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 7.41 [0.37; 148.78]
7.41 [0.37 ; 148.78 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable Eye disorders TRAE (grade 3-4)detailed results A3671009, 2013 0.98 [0.02; 49.62]
0.98 [0.02 ; 49.62 ] A3671009, 2013 1 0% 644 NA not evaluable Fatigue TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 3.70 [0.38; 35.82]
KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.05; 1.10]
KEYNOTE-002 (2 mg/kg), 2015 0.23 [0.05; 1.11]
0.48 [0.10 ; 2.26 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 57% 1,210 moderate not evaluable Hepatitis TRAE (grade 3-4)detailed results A3671009, 2013 3.94 [0.18; 87.81]
CA184-024, 2011 8.25 [0.43; 156.83]
KEYNOTE-002 (10 mg/kg), 2015 3.85 [0.17; 86.06]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
3.85 [0.77 ; 19.20 ] A3671009, 2013, CA184-024, 2011, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 4 0% 1,841 moderate not evaluable Hyperthyroidism TRAE (grade 3-4)detailed results CA184-024, 2011 1.02 [0.02; 51.42]
IMspire-150 (BRAF mutant), 2020 4.92 [0.22; 109.67]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
1.71 [0.27 ; 10.69 ] CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 4 0% 1,708 low not evaluable Hypophysitis TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.06; 57.80]
1.43 [0.11 ; 18.64 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Hypothyroidism TRAE (grade 3-4)detailed results CA184-024, 2011 1.02 [0.02; 51.42]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
0.98 [0.10 ; 9.42 ] CA184-024, 2011, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,197 moderate not evaluable Increase AST TRAE (grade 3-4)detailed results CA184-024, 2011 52.70 [7.19; 385.99]
52.70 [7.19 ; 385.99 ] CA184-024, 2011 1 0% 498 NA not evaluable Increased ALT TRAE (grade 3-4)detailed results CA184-024, 2011 32.40 [7.79; 134.72]
32.40 [7.79 ; 134.72 ] CA184-024, 2011 1 0% 498 NA not evaluable Increased lipase level TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 0.99 [0.64; 1.52]
0.99 [0.64 ; 1.52 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable Leucopenia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.07 [0.00; 1.17]
KEYNOTE-002 (2 mg/kg), 2015 0.07 [0.00; 1.17]
0.07 [0.01 ; 0.50 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Maculopapular rash TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 1.36 [0.78; 2.37]
KEYNOTE-002 (10 mg/kg), 2015 1.92 [0.06; 57.48]
KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.06; 57.80]
1.38 [0.80 ; 2.37 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 low not evaluable Myalgia TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 2.46 [0.22; 27.26]
KEYNOTE-002 (10 mg/kg), 2015 0.48 [0.02; 14.29]
KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.17; 21.50]
1.61 [0.35 ; 7.36 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 moderate not evaluable Nausea TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 0.17 [0.02; 1.40]
KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.03; 2.12]
KEYNOTE-002 (2 mg/kg), 2015 0.12 [0.01; 2.24]
0.18 [0.05 ; 0.69 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 moderate not evaluable Neutropenia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.08 [0.00; 1.39]
KEYNOTE-002 (2 mg/kg), 2015 0.08 [0.00; 1.40]
0.08 [0.01 ; 0.60 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Pancreatitis TRAE (grade 3-4)detailed results A3671009, 2013 5.93 [0.30; 118.96]
KEYNOTE-002 (10 mg/kg), 2015 1.92 [0.06; 57.48]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
2.61 [0.37 ; 18.36 ] A3671009, 2013, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,343 moderate not evaluable Paraesthesia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
0.96 [0.06 ; 15.38 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Peripheral neuropathy TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.24 [0.01; 5.29]
KEYNOTE-002 (2 mg/kg), 2015 0.24 [0.01; 5.32]
0.24 [0.03 ; 2.13 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Peripheral oedema TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 1.22 [0.02; 61.84]
1.22 [0.02 ; 61.84 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable Pneumonitis TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 4.92 [0.22; 109.67]
KEYNOTE-002 (10 mg/kg), 2015 5.81 [0.29; 116.90]
KEYNOTE-002 (2 mg/kg), 2015 1.93 [0.06; 57.80]
4.00 [0.65 ; 24.72 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 moderate not evaluable Pruritus TRAE (grade 3-4)detailed results CA184-024, 2011 10.35 [0.56; 190.49]
IMspire-150 (BRAF mutant), 2020 2.46 [0.22; 27.26]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
2.75 [0.59 ; 12.86 ] CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 4 0% 1,708 low not evaluable Pyrexia TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 1.22 [0.24; 6.13]
1.22 [0.24 ; 6.13 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable Rash TRAE (grade 3-4)detailed results CA184-024, 2011 6.16 [0.31; 123.62]
IMspire-150 (BRAF mutant), 2020 0.98 [0.53; 1.81]
KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
1.05 [0.58 ; 1.89 ] CA184-024, 2011, IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 4 0% 1,708 low not evaluable Thrombocytopenia TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.03; 2.12]
KEYNOTE-002 (2 mg/kg), 2015 0.12 [0.01; 2.24]
0.18 [0.03 ; 1.07 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Thyroiditis TRAE (grade 3-4)detailed results CA184-024, 2011 1.02 [0.02; 51.42]
1.02 [0.02 ; 51.42 ] CA184-024, 2011 1 0% 498 NA not evaluable Uveitis TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 1.92 [0.06; 57.48]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
1.42 [0.11 ; 18.63 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Vitiligo TRAE (grade 3-4)detailed results KEYNOTE-002 (10 mg/kg), 2015 0.96 [0.02; 48.41]
KEYNOTE-002 (2 mg/kg), 2015 0.96 [0.02; 48.69]
0.96 [0.06 ; 15.38 ] KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 2 0% 699 moderate not evaluable Vomiting TRAE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 0.48 [0.09; 2.52]
KEYNOTE-002 (10 mg/kg), 2015 0.23 [0.03; 2.12]
KEYNOTE-002 (2 mg/kg), 2015 0.24 [0.03; 2.13]
0.33 [0.11 ; 1.03 ] IMspire-150 (BRAF mutant), 2020, KEYNOTE-002 (10 mg/kg), 2015, KEYNOTE-002 (2 mg/kg), 2015 3 0% 1,210 moderate not evaluable Abdominal pain AE (grade 3-4)detailed results A3671009, 2013 4.04 [1.13; 14.45]
CA184-024, 2011 0.43 [0.11; 1.68]
1.33 [0.15 ; 12.01 ] A3671009, 2013, CA184-024, 2011 2 82% 1,142 moderate not evaluable Asthenia AE (grade 3-4)detailed results A3671009, 2013 0.10 [0.01; 1.78]
CA184-024, 2011 0.17 [0.02; 1.39]
0.14 [0.02 ; 0.77 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 low not evaluable Chills AE (grade 3-4)detailed results CA184-024, 2011 1.02 [0.02; 51.42]
1.02 [0.02 ; 51.42 ] CA184-024, 2011 1 0% 498 NA not evaluable Constipation AE (grade 3-4)detailed results A3671009, 2013 0.98 [0.14; 7.01]
CA184-024, 2011 1.02 [0.02; 51.42]
0.99 [0.17 ; 5.73 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable Cough AE (grade 3-4)detailed results A3671009, 2013 1.97 [0.07; 58.81]
CA184-024, 2011 2.04 [0.07; 60.99]
2.00 [0.18 ; 22.13 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable Decreased appetite AE (grade 3-4)detailed results A3671009, 2013 14.32 [1.87; 109.52]
CA184-024, 2011 0.76 [0.17; 3.43]
3.03 [0.17 ; 53.71 ] A3671009, 2013, CA184-024, 2011 2 81% 1,142 low not evaluable Diarrhoea AE (grade 3-4)detailed results CA184-024, 2011 21.14 [1.23; 363.94]
21.14 [1.23 ; 363.94 ] CA184-024, 2011 1 0% 498 NA not evaluable Dyspnoea AE (grade 3-4)detailed results A3671009, 2013 4.00 [0.84; 18.98]
CA184-024, 2011 16.77 [0.96; 293.61]
5.55 [1.41 ; 21.79 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable Fatigue AE (grade 3-4)detailed results A3671009, 2013 3.90 [1.44; 10.57]
CA184-024, 2011 2.44 [1.21; 4.94]
2.86 [1.61 ; 5.08 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 low not evaluable Headache AE (grade 3-4)detailed results A3671009, 2013 1.97 [0.18; 21.82]
CA184-024, 2011 4.12 [0.46; 37.08]
2.94 [0.58 ; 14.91 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 low not evaluable Hypothyroidism AE (grade 3-4)detailed results IMspire-150 (BRAF mutant), 2020 1.22 [0.02; 61.84]
1.22 [0.02 ; 61.84 ] IMspire-150 (BRAF mutant), 2020 1 0% 511 NA not evaluable Increase AST AE (grade 3-4)detailed results CA184-024, 2011 18.42 [5.64; 60.14]
18.42 [5.64 ; 60.14 ] CA184-024, 2011 1 0% 498 NA not evaluable Increased ALT AE (grade 3-4)detailed results CA184-024, 2011 34.83 [8.39; 144.67]
34.83 [8.39 ; 144.67 ] CA184-024, 2011 1 0% 498 NA not evaluable Nausea AE (grade 3-4)detailed results A3671009, 2013 1.39 [0.61; 3.18]
CA184-024, 2011 1.36 [0.30; 6.14]
1.38 [0.67 ; 2.86 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable Neutropenia AE (grade 3-4)detailed results A3671009, 2013 0.03 [0.00; 0.19]
0.03 [0.00 ; 0.19 ] A3671009, 2013 1 0% 644 NA not evaluable Peripheral oedema AE (grade 3-4)detailed results A3671009, 2013 4.97 [0.58; 42.77]
4.97 [0.58 ; 42.77 ] A3671009, 2013 1 0% 644 NA not evaluable Pruritus AE (grade 3-4)detailed results A3671009, 2013 5.93 [0.30; 118.96]
CA184-024, 2011 10.35 [0.56; 190.49]
7.90 [0.98 ; 63.82 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 low not evaluable Pyrexia AE (grade 3-4)detailed results A3671009, 2013 7.94 [0.42; 150.76]
CA184-024, 2011 1.02 [0.02; 51.42]
3.79 [0.36 ; 39.89 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable Rash AE (grade 3-4)detailed results A3671009, 2013 7.00 [0.86; 57.23]
CA184-024, 2011 6.16 [0.31; 123.62]
6.71 [1.20 ; 37.51 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable Thrombocytopenia AE (grade 3-4)detailed results A3671009, 2013 0.03 [0.00; 0.26]
0.03 [0.00 ; 0.26 ] A3671009, 2013 1 0% 644 NA not evaluable Vomiting AE (grade 3-4)detailed results A3671009, 2013 1.55 [0.66; 3.64]
CA184-024, 2011 2.07 [0.61; 6.95]
1.70 [0.85 ; 3.42 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable Weight decreased AE (grade 3-4)detailed results A3671009, 2013 0.98 [0.06; 15.76]
CA184-024, 2011 1.02 [0.06; 16.34]
1.00 [0.14 ; 7.12 ] A3671009, 2013, CA184-024, 2011 2 0% 1,142 moderate not evaluable 0.0 100.0 1.0 relative treatment effect www.metaEvidence.org 2024-10-02 03:53 +02:00
TE: relative treatment effect (measured by a risk ratio, an odds ratio or an hazard ratio depending on what is reported in the papers);
k: number of studies; n: total number of patients;
ROB: risk of bias (ROB 2.0); Pub. bias: publication bias; OBS: observational studies; RCT: randomized clinical trials
studied treatment is better when TE > 1;
studied treatment is better when TE < 1;
pathologies: 2,283,284,70,235,285,68,127,128,286,69,129
- treatments: 204,504,850,329,558,579,549,868,502,741,556,812,813,367,851,361,602,1070,671,865,744,696,1083,1281,1282,1283,1082,866,852,417,603,1051,876,853,1018,661,673,1049,1440,1561,854,374,953,672,1080,1560,1073,862,1562,1565,855,360,719,721,720,842,642,674,1085,863,503,847,982,359,575,577,576,869,1081,981,875,505,952,1021,1079,767,1071,1074,873,561,644,1251,1044,724,874,1043,1041,1042,940,1258,1563,746,745,856,634,861,416,864,769,980,369,743