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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

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