Page 237 - 2021_02-Haematologica-web

The CLL2-BIO trial
Table 3B. Adverse events during induction with ofatumumab and ibrutinib reported in ≥5% of patients: data are number of patients (%).
Maximumgrade
Patients with AE
Blood and lymphatic system disorders
Neutropenia
Treatment-naïve Relapsed/refractory All patients (n=40) (n=26) (n=66)
1/2 3 4 5 1/2 3 4 5 1/2 3 4 5
21 (53%) 14 (35%) 5 (13%) 0 11 (42%) 11 (42%) 3 (12%) 1 (4%) 32 (48%) 25 (38%) 8 (12%) 1 (2%)
0 4(10%) 4(10%) 0 4(15%) 5(19%) 3(12%) 0 4(6%) 9(14%) 7(11%) 0
0 3(8%) 4(10%) 0 0 5(19%) 2(8%) 0 0 8(12%) 6(9%) 0
Thrombocytopenia 0 0 0
0 2(8%) 1(4%) 1(4%) 0 2(3%) 1(2%) 1(2%) 0
0 2(8%) 1(4%) 0 0 7(11%) 3(5%) 0 0
0 1(4%) 1(4%) 0 0 2(3%) 3(5%) 0 0
Cardiacdisorders 5(13%) 2(5%)
Atrialfibrillation 1(3%) 2(5%)
Earandlabyrinthdisorders 2(5%) 0
0
0
Eye disorders
Gastrointestinal disorders
Diarrhea
Abdominal pain
Oral soft tissue conditions Dyspepsia
Nausea
Gastroesophageal reflux
General disorders and administration site conditions
Fatigue Edema
Immune system disorders
Infections and infestations
Upper repiratory tract inf.
Lower repiratory tract inf.
Infections NEC
Dental/oral soft tissue inf.
Urinary tract infections
Abdominal GI infections
Oralherpes 4(10%)
Conjunctivitis
Injury, poisoning and procedural complications Infusion-related reaction
Investigations
Metabolism and nutrition disorders
Musculoskeletal/connective tissue disorders
Muscle disorders Musculoskeletal/connective
tissue disorders NEC
Arthralgia
Neoplasms benign/malignant*
Nervous system disorders
Dizziness Headaches Par-/dysesthesias
Psychiatric disorders
Renal and urinary disorders
Urinary tract signs/symptoms
Respiratory, thoracic and mediastinal disorders
Cough
Epistaxis Pneumonitis Oropharyngeal pain
3 (8%)
20 (50%)
16 (40%)
4 (10%) 5 (13%)
22 (55%)
10 (25%) 9 (23%)
6 (15%)
0
10 (25%)
3 (8%) 3 (8%) 3 (8%)
2 (5%)
2 (5%)
2 (5%)
10 (25%)
5 (13%) 3 (8%) 2 (5%) 3 (8%)
6 (15%)
21 (53%)
12 (30%) 4 (10%) 4 (10%) 3 (8%) 3 (8%) 2 (5%)
17 (43%)
9 (23%) 3 (8%)
1 (3%)
1 (3%)
3 (8%)
3 (8%) 0
0
0
0
0
0
0 0
0
2 (5%) 0
0
0
0
0
1 (3%) 0
0
3 (8%)
2 (5%)
0 0
2 (5%)
1 (3%) 1 (3%)
0
1 (3%)
2 (5%)
0 0 0
0
0
0
1 (3%)
0 0 0 0
27 (68%) 16 (40%) 2 (5%) 3 (8%) 4 (10%) 4 (10%) 2 (5%)
0 0
0 0
0 0
0 0 0 0 0 0 0 0 0 0 0 0
0 0
0 0 0 0
0 0
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
0 0
0 0
0 0 0 0
0 0
0 0 0 0
0 0
1 (3%) 0
0 0
0 0 0 0 0 0
0 0
0 0
0 0
0 0
0 0 0 0 0 0 0 0
2(8%) 0 0 0 4(6%) 0 0 0
continued on the next pag
5(19%) 0
9(35%) 2(8%)
6(23%) 1(4%) 4(15%) 0 2(8%) 0 2(8%) 0 2(8%) 0 3(12%) 0
8(31%) 1(4%)
5(19%) 0 3(12%) 0
3(12%) 0
8 (31%) 4 (15%) 4(15%) 0 3(12%) 2(8%)
2(8%) 1(4%) 1(4%) 0 1(4%) 0
0 1(4%)
0 0
0 0
0 0 0 0 0 0 0 0 0 0 0 0
0 0
0 0 0 0
0 0
0000
1(4%) 0 0 0
9(35%) 3(12%) 0 0
8(31%) 3(12%) 0 0
0 0 0 0 0 0 0
1 (4%) 0
0
0
0
0
0
11(17%) 1(2%)
30(45%) 5(8%)
18(27%) 4(6%) 8(12%) 0 6(9%) 0 5(8%) 0 5(8%) 0 5(8%) 0
25(38%) 1(2%)
14(21%) 0 6(9%) 0
4(6%) 0
0 0
0 0
0 0 0 0 0 0 0 0 0 0 0 0
0 0
0 0 0 0
0 0
35 (53%) 20(30%) 5(8%) 5(8%)
6 (9%) 0 2(3%) 1(2%)
0
0
0
0
0
0
0
0
0 0
5(8%) 0 5(8%) 0 2(3%) 2(3%) 4(6%) 0 4(6%) 0
29(44%) 6(9%)
24(36%) 5(8%)
1 (2%) 0
0
0
0
0
0
0
0 0
0 0
3(12%) 0 0 0 4(15%) 0 0 0
10(38%) 0 0 0
7(27%) 0 0 0 2(8%) 0 0 0
3(12%) 0 0 0
1(4%) 2(8%) 0 0
7(27%) 2(8%) 0 0
2(8%) 0 0 0 1(4%) 0 0 0 1(4%) 0 0 0
2(8%) 0 0 0
7(11%) 0 0 0 9(14%) 0 0 0
32(48%) 2(3%) 0 0
17(26%) 1(2%) 0 0 11(17%) 1(2%) 0 0
9(14%) 0 0 0
1(2%) 3(5%) 1(2%) 0
17(26%) 4(6%) 0 0
5(8%) 0 0 0 4(6%) 0 0 0 4(6%) 0 0 0
4(6%) 0 0 0
3(12%) 0 0 0
3(12%) 0 0 0
9(35%) 1(4%) 0 0
4(15%) 0 0 0 4(15%) 0 0 0 1(4%) 1(4%) 0 0 1(4%) 0 0 0
5(8%) 0 0 0
5(8%) 0 0 0
19(29%) 2(3%) 0 0
9(14%) 0 0 0 7(11%) 0 0 0 3(5%) 1(2%) 0 0 4(6%) 0 0 0
haematologica | 2021; 106(2)
551
e