Table 2 Adverse events

Neuropathy

Any grade

6

844

1127

676

1182

2.10 (1.37, 3.23)

0.001

71.6

0.003

Grade ≥ 3

4

87

1083

23

1076

4.01 (2.51, 6.41)

< 0.001

0.0

0.458

Increased ALT

Any grade

2

364

942

379

936

0.91 (0.74, 1.12)

0.356

42.3

0.188

Grade ≥ 3

2

16

942

17

936

0.93 (0.47, 1.86)

0.846

61.0

0.109

Increased AST

Any grade

2

250

942

235

936

1.09 (0.87, 1.36)

0.451

0.9

0.315

Grade ≥ 3

2

6

942

6

936

0.99 (0.33, 2.96)

0.991

32.5

0.224

Liver function abnormalities

Any grade

1

11

14

9

16

2.85 (0.57, 14.33)

0.203

NA

NA

Grade ≥ 3

1

2

14

0

16

6.60 (0.29, 150.07)

0.236

NA

NA

Fatigue

Any grade

4

670

1030

622

1029

1.27 (1.04, 1.55)

0.018

0.0

0.495

Grade ≥ 3

4

39

1030

29

1029

1.35 (0.83, 2.20)

0.225

0.0

0.622

Diarrhea/constipation

Any grade

5

429

1060

420

1119

1.21 (1.01, 1.45)

0.010

0.0

0.638

Grade ≥ 3

4

28

1046

22

1103

1.35 (0.77, 2.36)

0.297

0.0

0.713

Rash

Any grade

3

61

381

71

441

1.15 (0.78, 1.69)

0.484

0.0

0.634

Grade ≥ 3

2

1

367

3

425

1.08 (0.02, 67.43)

0.970

71.9

0.059

Neutropenia

Any grade

5

765

1060

748

1119

1.53 (1.24, 1.89)

< 0.001

0.9

0.401

Grade ≥ 3

4

528

1046

520

1103

1.33 (0.74, 2.39)

0.333

81.2

0.001

Leucopenia

Any grade

4

731

1046

766

1103

1.22 (0.93, 1.58)

0.146

0.0

0.831

Grade ≥ 3

4

347

1046

353

1103

1.29 (0.73, 2.320)

0.380

75.9

0.006

Hypersensitivity

Any grade

1

6

337

20

335

0.29 (0.11, 0.72)

0.008

NA

NA

Grade ≥ 3

1

1

337

2

335

0.50 (0.04, 5.49)

0.567

NA

NA

Myalgia

Any grade

2

211

679

176

678

1.29 (1.02, 1.63)

0.036

0.0

0.334

Grade ≥ 3

1

2

679

0

678

4.98 (0.24, 104.02)

0.3

NA

NA

Arthralgia

Any grade

2

249

679

239

678

1.06 (0.85, 1.33)

0.582

10.7

0.29

Grade ≥ 3

1

5

679

1

678

5.0 (0.58, 42.92)

0.140

NA

NA

Alopecia

Any grade

2

608

679

627

678

0.50 (0.12, 2.12)

0.347

90.1

0.001

Grade ≥ 3

2

0

679

0

678

NA

NA

NA

NA

Anemia

Any grade

2

588

635

597

691

1.86 (1.28, 2.71)

0.001

23.3

0.254

Grade ≥ 3

2

18

635

7

691

3.89 (1.55, 9.72)

< 0.001

0.0

0.547

Nausea

Any grade

5

688

1060

738

1119

1.02 (0.85, 1.22)

0.869

0.0

0.463

Grade ≥ 3

3

30

1046

28

1103

1.12 (0.67, 1.89)

0.659

9.0

0.333

Vomiting

Any grade

4

266

1046

299

1103

1.13 (0.92, 1.39)

0.253

9.5

0.345

Grade ≥ 3

3

23

1046

19

1103

1.30 (0.70, 2.39)

0.404

46.2

0.156