Treatment-emergent AEs
| Event term* . | Grade 1, n (%) . | Grade 2, n (%) . | Grade 3, n (%) . | Grade 4, n (%) . | Grade 5, n (%) . | All grade, n (%) . |
|---|---|---|---|---|---|---|
| Patients with ≥1 AE | 5 (6.5) | 27 (35.1) | 30 (39.0) | 10 (13.0) | 5 (6.5) | 77 (100.0) |
| Nonhematologic AEs | ||||||
| Upper respiratory tract infection | 1 (1.3) | 39 (50.6) | 0 | 0 | 0 | 40 (51.9) |
| Contusion | 25 (32.5) | 0 | 0 | 0 | 0 | 25 (32.5) |
| Cough | 16 (20.8) | 1 (1.3) | 0 | 0 | 0 | 17 (22.1) |
| Diarrhea | 8 (10.4) | 5 (6.5) | 2 (2.6) | 0 | 0 | 15 (19.5) |
| Urinary tract infection | 1 (1.3) | 13 (16.9) | 1 (1.3) | 0 | 0 | 15 (19.5) |
| Headache | 8 (10.4) | 4 (5.2) | 2 (2.6) | 0 | 0 | 14 (18.2) |
| Rash | 11 (14.3) | 2 (2.6) | 0 | 0 | 0 | 13 (16.9) |
| Hypertension | 1 (1.3) | 8 (10.4) | 3 (3.9) | 0 | 0 | 12 (15.6) |
| Constipation | 7 (9.1) | 5 (6.5) | 0 | 0 | 0 | 12 (15.6) |
| Back pain | 10 (13.0) | 2 (2.6) | 0 | 0 | 0 | 12 (15.6) |
| Fatigue | 11 (14.3) | 1 (1.3) | 0 | 0 | 0 | 12 (15.6) |
| Gastroesophageal reflux disease | 7 (9.1) | 4 (5.2) | 0 | 0 | 0 | 11 (14.3) |
| Nausea | 8 (10.4) | 3 (3.9) | 0 | 0 | 0 | 11 (14.3) |
| Cellulitis | 1 (1.3) | 5 (6.5) | 4 (5.2) | 0 | 0 | 10 (13.0) |
| Epistaxis | 9 (11.7) | 1 (1.3) | 0 | 0 | 0 | 10 (13.0) |
| Oropharyngeal pain | 8 (10.4) | 2 (2.6) | 0 | 0 | 0 | 10 (13.0) |
| Petechiae | 10 (13.0) | 0 | 0 | 0 | 0 | 10 (13.0) |
| Pruritus | 9 (11.7) | 1 (1.3) | 0 | 0 | 0 | 10 (13.0) |
| Basal cell carcinoma | 1 (1.3) | 4 (5.2) | 0 | 0 | 0 | 9 (11.7) |
| Arthralgia | 4 (5.2) | 4 (5.2) | 1 (1.3) | 0 | 0 | 9 (11.7) |
| Fall | 2 (2.6) | 4 (5.2) | 2 (2.6) | 0 | 0 | 8 (10.4) |
| Lower respiratory tract infection | 0 | 8 (10.4) | 0 | 0 | 0 | 8 (10.4) |
| Pneumonia | 0 | 1 (1.3) | 3 (3.9) | 0 | 0 | 4 (5.2) |
| Actinic keratosis | 1 (1.3) | 0 | 2 (2.6) | 0 | 0 | 3 (3.9) |
| Hematologic AEs | ||||||
| Neutropenia† | 0 | 2 (2.6) | 6 (7.8) | 6 (7.8) | 0 | 14 (18.2) |
| Anemia | 1 (1.3) | 3 (3.9) | 7 (9.1) | 0 | 0 | 11 (14.3) |
| Event term* . | Grade 1, n (%) . | Grade 2, n (%) . | Grade 3, n (%) . | Grade 4, n (%) . | Grade 5, n (%) . | All grade, n (%) . |
|---|---|---|---|---|---|---|
| Patients with ≥1 AE | 5 (6.5) | 27 (35.1) | 30 (39.0) | 10 (13.0) | 5 (6.5) | 77 (100.0) |
| Nonhematologic AEs | ||||||
| Upper respiratory tract infection | 1 (1.3) | 39 (50.6) | 0 | 0 | 0 | 40 (51.9) |
| Contusion | 25 (32.5) | 0 | 0 | 0 | 0 | 25 (32.5) |
| Cough | 16 (20.8) | 1 (1.3) | 0 | 0 | 0 | 17 (22.1) |
| Diarrhea | 8 (10.4) | 5 (6.5) | 2 (2.6) | 0 | 0 | 15 (19.5) |
| Urinary tract infection | 1 (1.3) | 13 (16.9) | 1 (1.3) | 0 | 0 | 15 (19.5) |
| Headache | 8 (10.4) | 4 (5.2) | 2 (2.6) | 0 | 0 | 14 (18.2) |
| Rash | 11 (14.3) | 2 (2.6) | 0 | 0 | 0 | 13 (16.9) |
| Hypertension | 1 (1.3) | 8 (10.4) | 3 (3.9) | 0 | 0 | 12 (15.6) |
| Constipation | 7 (9.1) | 5 (6.5) | 0 | 0 | 0 | 12 (15.6) |
| Back pain | 10 (13.0) | 2 (2.6) | 0 | 0 | 0 | 12 (15.6) |
| Fatigue | 11 (14.3) | 1 (1.3) | 0 | 0 | 0 | 12 (15.6) |
| Gastroesophageal reflux disease | 7 (9.1) | 4 (5.2) | 0 | 0 | 0 | 11 (14.3) |
| Nausea | 8 (10.4) | 3 (3.9) | 0 | 0 | 0 | 11 (14.3) |
| Cellulitis | 1 (1.3) | 5 (6.5) | 4 (5.2) | 0 | 0 | 10 (13.0) |
| Epistaxis | 9 (11.7) | 1 (1.3) | 0 | 0 | 0 | 10 (13.0) |
| Oropharyngeal pain | 8 (10.4) | 2 (2.6) | 0 | 0 | 0 | 10 (13.0) |
| Petechiae | 10 (13.0) | 0 | 0 | 0 | 0 | 10 (13.0) |
| Pruritus | 9 (11.7) | 1 (1.3) | 0 | 0 | 0 | 10 (13.0) |
| Basal cell carcinoma | 1 (1.3) | 4 (5.2) | 0 | 0 | 0 | 9 (11.7) |
| Arthralgia | 4 (5.2) | 4 (5.2) | 1 (1.3) | 0 | 0 | 9 (11.7) |
| Fall | 2 (2.6) | 4 (5.2) | 2 (2.6) | 0 | 0 | 8 (10.4) |
| Lower respiratory tract infection | 0 | 8 (10.4) | 0 | 0 | 0 | 8 (10.4) |
| Pneumonia | 0 | 1 (1.3) | 3 (3.9) | 0 | 0 | 4 (5.2) |
| Actinic keratosis | 1 (1.3) | 0 | 2 (2.6) | 0 | 0 | 3 (3.9) |
| Hematologic AEs | ||||||
| Neutropenia† | 0 | 2 (2.6) | 6 (7.8) | 6 (7.8) | 0 | 14 (18.2) |
| Anemia | 1 (1.3) | 3 (3.9) | 7 (9.1) | 0 | 0 | 11 (14.3) |
MedDRA, Medical Dictionary for Regulatory Activities.
Data are for treatment-emergent AEs in the 77 zanubrutinib-treated patients with WM included in the study. Listed events occurred in >10% of patients (in >2% of patients for grade ≥3) on or before the data cutoff date of August 31, 2019.
Includes the MedDRA-preferred terms neutropenia, neutrophil count decreased, and febrile neutropenia.