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