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Table 5 Any grade AEs (≥10%) and corresponding Grade 3 or 4 AEs (Safety population)

From: A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer

 

BTH1677/

Bevacizumab/

Carboplatin/Paclitaxel

(N = 59)

Bevacizumab/

Carboplatin/Paclitaxel

(N = 30)

Adverse events (AEs), n (%)

All AEs

Grade 3 or Grade 4 AEs

All AEs

Grade 3 or Grade 4 AEs

Patients with at least 1 AE

58 (98.3)

55 (93.2)

30 (100.0)

20 (66.7)

Blood and lymphatic system disorders

 Neutropenia

26 (44.1)

23 (39.0)

10 (33.3)

8 (26.7)

 Thrombocytopenia

20 (33.9)

11 (18.6)

10 (33.3)

5 (16.7)

 Anemia

14 (23.7)

2 (3.4)

8 (26.7)

1 (3.3)

 Leukopenia

9 (15.3)

3 (5.1)

2 (6.7)

1 (3.3)

Gastrointestinal disorders

 Nausea

40 (67.8)

5 (8.5)

16 (53.3)

0

 Constipation

25 (42.4)

0

9 (30.0)

0

 Vomiting

19 (32.2)

2 (3.4)

7 (23.3)

0

 Diarrhea

12 (20.3)

2 (3.4)

8 (26.7)

1 (3.3)

 Abdominal pain upper

6 (10.2)

1 (1.7)

1 (3.3)

0

 Stomatitis

6 (10.2)

1 (1.7)

0

0

General disorders and administration-site conditions

 Fatigue

33 (55.9)

1 (1.7)

18 (60.0)

1 (3.3)

 Pyrexia

12 (20.3)

2 (3.4)

3 (10.0)

0

 Chills

11 (18.6)

1 (1.7)

0

0

 Mucosal inflammation

6 (10.2)

0

3 (10.0)

0

 Chest pain

3 (5.1)

0

5 (16.7)

0

Infections and infestations

 Nasopharyngitis

6 (10.2)

0

3 (10.0)

0

 Urinary tract infection

2 (3.4)

1 (1.7)

3 (10.0)

0

Injury, poisoning, and procedural complications

 Infusion-related reaction

7 (11.9)

1 (1.7)

2 (6.7)

1 (3.3)

Investigations

 Hemoglobin decreased

4 (6.8)

1 (1.7)

3 (10.0)

2 (6.7)

 Platelet count decreased

3 (5.1)

2 (3.4)

3 (10.0)

1 (3.3)

Metabolism and nutritional disorders

 Decreased appetite

17 (28.8)

1 (1.7)

11 (36.7)

0

 Hypokalemia

6 (10.2)

1 (1.7)

0

0

Musculoskeletal and connective tissue disorders

 Arthralgia

19 (32.2)

1 (1.7)

6 (20.0)

0

 Pain in extremity

15 (25.4)

0

3 (10.0)

0

 Back pain

11 (18.6)

1 (1.7)

4 (13.3)

0

 Myalgia

12 (20.3)

1 (1.7)

2 (6.7)

0

Nervous system disorders

 Polyneuropathy

16 (27.1)

3 (5.1)

6 (20.0)

0

 Headache

9 (15.3)

1 (1.7)

4 (13.3)

0

 Neuropathy peripheral

6 (10.2)

0

5 (16.7)

0

 Dizziness

7 (11.9)

0

3 (10.0)

0

 Paresthesia

7 (11.9)

0

2 (6.7)

0

 Dysgeusia

6 (10.2)

0

2 (6.7)

0

Psychiatric disorders

 Insomnia

9 (15.3)

0

2 (6.7)

0

 Sleep disorder

5 (8.5)

0

4 (13.3)

0

Respiratory, thoracic and mediastinal disorders

 Dyspnea

18 (30.5)

3 (5.1)

8 (26.7)

0

 Cough

18 (30.5)

2 (3.4)

7 (23.3)

0

 Epistaxis

14 (23.7)

0

10 (33.3)

0

 Oropharyngeal pain

8 (13.6)

0

2 (6.7)

0

Skin and subcutaneous tissue disorders

 Alopecia

28 (47.5)

2 (3.4)

14 (46.7)

0

Vascular disorders

 Hypertension

14 (23.7)

3 (5.1)

7 (23.3)

1 (3.3)

  1. Abbreviations: AE adverse events, N overall sample size, n number of patients