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Table 2 Summary results of the all-grade and grade ≥ 3 adverse events (AEs) in mogamulizumab monotherapy

From: Safety and efficacy profile of mogamulizumab (Poteligeo) in the treatment of cancers: an update evidence from 14 studies

adverse events All-grade Grade ≥ 3
No. of Studies No. of Patients model Event rate with 95% CI Z value p value No. of Studies No. of Patients model Event rate with 95% CI Z value p value
KW-0761 < =0.1 mg/kg
 Hematologic
  Lymphopenia 2 10 Fixed 0.700 (0.375–0.900) 1.224 0.221 2 10 Fixed 0.401 (0.158–0.705) − 0.619 0.536
  Nonhematologic  
  Fever 2 10 Fixed 0.212 (0.052–0.569) −1.618 0.106       
  Rash 2 10 Random 0.351 (0.045–0.860) −0.497 0.619       
KW-0761 = 0.5 mg/kg
 Hematologic
  Leukopenia 2 6 Fixed 0.875 (0.463–0.983) 1.820 0.069 2 6 Fixed 0.767 (0.337–0.955) 1.250 0.211
  Lymphopenia 2 6 Fixed 0.875 (0.463–0.983) 1.820 0.069       
  Neutropenia 2 6 Fixed 0.587 (0.181–0.902) 0.370 0.711       
 KW-0761 = 1.0 mg/kg
  Hematologic
  Anaemia 5 316o Random 0.097 (0.040–0.216) −4.626 0.000 3 122 Fixed 0.056 (0.025–0.119) −6.720 0.000
  Leukopenia 5 127 Random 0.310 (0.125–0.586) −1.368 0.171       
  Lymphopenia 4 80 Random 0.805 (0.432–0.957) 1.643 0.100 3 43 Random 0.648 (0.482–0.787) 1.757 0.079
  Neutropenia 6 165 Random 0.228 (0.104–0.431) −2.543 0.011 5 155 Fixed 0.139 (0.087–0.213) −6.915 0.000
  Thrombocytopenia 4 149 Random 0.273 (0.131–0.483) −2.108 0.035 4 149 Fixed 0.117 (0.071–0.185) −7.311 0.000
Gastrointestinal disorders
 Diarrhea 3 90 Fixed 0.158 (0.096–0.249) −5.743 0.000       
 Vomiting 2 80 Fixed 0.128 (0.107–0.154) −5.617 0.000       
 Nausea 4 154 Random 0.147 (0.064–0.304) −3.716 0.000 2 80 Fixed 0.039 (0.013–0.114) − 5.436 0.000
General disorders
 Chills 2 69 Random 0.401 (0.129–0.751) −0.522 0.602       
 Fatigue 2 89 Random 0.096 (0.024–0.312) − 3.022 0.003       
 Fever 3 43 Random 0.472 (0.116–0.859) −0.116 0.907       
 Pyrexia 5 348 Random 0.139 (0.062–0.283) −4.002 0.000       
 Headache 3 127 Random 0.115 (0.046–0.259) −4.048 0.000       
Infections and infestations
 Infection 2 84 Random 0.081 (0.015–0.335) −2.730 0.006 2 84 Fixed 0.084 (0.038–0.175) −5.571 0.000
Injury, poisoning and procedural complications
 Infusion reaction 2 64 Random 0.607 (0.062–0.973) 0.272 0.786       
 Infusion-related reaction 4 311 Random 0.135 (0.032–0.420) −2.370 0.018       
Metabolism and nutrition disorders /investigations
 ALT 4 121 Random 0.172 (0.063–0.391) −2.731 0.006 3 111 Fixed 0.042 (0.016–0.107) −6.107 0.000
 AST 3 84 Random 0.167 (0.040–0.494) −1.990 0.047 2 74 Fixed 0.049 (0.016–0.140) −5.007 0.000
 Decreased appetite 2 231 Random 0.017 (0.002–0.119) −3.885 0.000       
 CRP 2 16 Fixed 0.128 (0.032–0.395) −2.521 0.012       
 Hypercalcemia 2 37 Fixed 0.108 (0.041–0.255) − 3.983 0.000       
 Hypertension 2 33 Fixed 0.277 (0.150–0.453) − 2.443 0.015       
 Hyperuricemia 2 37 Fixed 0.137 (0.058–0.289) −3.825 0.000       
 Hypokalemia 2 64 Fixed 0.083 (0.035–0.184) −5.133 0.000 2 64 Fixed 0.053 (0.017–0.151) −4.857 0.000
 Hypophosphatemia 2 64 Fixed 0.156 (0.086–0.267) − 4895 0.000       
 Hypotension 2 65 Fixed 0.139 (0.074–0.246) −5.084 0.000       
 Weight change 2 74 Random 0.077 (0.008–0.447) −2.143 0.032       
Musculoskeletal and connective tissue disorders
 Polymyositis 2 221 Fixed 0.012 (0.003–0.047) −6.179 0.000       
 Arthralgia 2 222 Random 0.036 (0.004–0.278) −2.767 0.006       
Respiratory, thoracic and mediastinal disorders
 Hypoxemia 2 33 Fixed 0.182 (0.084–0.350) −3.330 0.001       
 Pneumonia 2 221 Fixed 0.023 (0.009–0.053) −8.316 0.000 2 75 Fixed 0.042 (0.014–0.123) −5.293 0.000
Skin and subcutaneous tissue disorders
 Pruritus 4 113 Fixed 0.153 (0.097–0.232) −6.497 0.000       
 Rash 4 88 Random 0.407 (0.210–0.639) −0.782 0.434 3 48 Fixed 0.135 (0.074–0.234) −5.423 0.000
 Rash maculopapular 2 47 Fixed 0.101 (0.038–0.243) −4.085 0.000       
 Drug eruption 3 269 Random 0.111 (0.022–0.412) −2.365 0.018