Safety (46.9 Month Follow up)
Most Common AEs ≥25% of Patients1
| A-O (n=178) | A (n=179) | O-Clb (n=169) | ||||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Diarrhea | 73 (41.0) | 9 (5.1) | 72 (40.2) | 1 (0.6) | 36 (21.3) | 3 (1.8) |
| Headache | 71 (39.9) | 2 (1.1) | 68 (38.0) | 2 (1.1) | 20 (11.8) | 0 |
| Neutropenia | 60 (33.7) | 55 (30.9) | 22 (12.3) | 20 (11.2) | 76 (45.0) | 70 (41.4) |
| Fatigue | 50 (28.1) | 4 (2.2) | 39 (21.8) | 2 (1.1) | 30 (17.8) | 2 (1.2) |
| Arthralgia | 47 (26.4) | 2 (1.1) | 35 (19.6) | 2 (1.1) | 8 (4.7) | 2 (1.2) |
| Cough | 46 (25.8) | 1 (0.6) | 40 (22.3) | 1 (0.6) | 15 (8.9) | 0 |
| Upper respiratory tract infection | 44 (24.7) | 4 (2.2) | 46 (25.7) | 0 | 16 (9.5) | 1 (0.6) |
| Nausea | 41 (23.0) | 0 | 41 (22.9) | 0 | 53 (31.4) | 0 |
| Infusion-related reaction | 25 (14.0) | 5 (2.8) | 0 | 0 | 68 (40.2) | 10 (5.9) |
Most AEs with acalabrutinib occurred in the first year1
Most Common AEs with Acalabrutinib1
Most Common AEs with Acalabrutinib1
Note: A patient with multiple severity grades for a given AE was counted only once under the maximum severity. Multiple onsets of the same AE within a specific yearly interval were counted once, and the same AE term continuing across several yearly intervals was counted in each of the intervals.
aO-Clb treatment was of fixed duration of 6 cycles; bA-O (n=178), A (n=179), O-Clb (n=169); cA-O (n=160), A (n=154), O-Clb (n=0); dA-O (n=150), A (n=146), O-Clb (n=0); eA-O (n=144), A (n=134), O-Clb (n=0); fA-O (n=80), A (n=76), O-Clb (n=0).
Cumulative Incidence KM Curves for Select AEs2
- Atrial Fibrillation
- Hypertension
- Diarrhea
- Hemorrhage
- Infections
Events of Clinical Interest1
| A-O (n=178) | A (n=179) | O-Clb (n=169) | ||||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Cardiac eventsa | 37 (20.8) | 14 (7.9)b | 34 (19.0) | 15 (8.4)c | 13 (7.7) | 3 (1.8) |
| 7 (3.9) | 1 (0.6) | 11 (6.1) | 2 (1.1) | 1 (0.6) | 0 |
| Bleeding | 84 (47.2) | 5 (2.8) | 75 (41.9) | 5 (2.8) | 20 (11.8) | 0 |
| 7 (3.9) | 5 (2.8) | 7 (3.9) | 5 (2.8) | 2 (1.2) | 0 |
| Hypertension | 14 (7.9) | 6 (3.4) | 13 (7.3) | 5 (2.8) | 7 (4.1) | 6 (3.6) |
| Infections | 134 (75.3) | 42 (23.6) | 132 (73.7) | 29 (16.2) | 75 (44.4) | 14 (8.3) |
| SPMs | 28 (15.7) | 13 (7.3) | 24 (13.4) | 5 (2.8) | 7 (4.1) | 3 (1.8) |
| 15 (8.4) | 10 (5.6) | 11 (6.1) | 4 (2.2) | 3 (1.8) | 2 (1.2) |
Note: Data are n (%) unless otherwise specified.
aCardiac events that occurred in >1 patient (any grade; other than atrial fibrillation) in any group include angina pectoris, palpitations, atrioventricular block complete, myocardial ischemia, tachycardia, bradycardia, cardiac failure, left ventricular failure, myocardial infarction, pericardial effusion, acute myocardial infarction, and supraventricular tachycardia; bCardiac events (grade ≥3) that occurred in >1 patient (other than atrial fibrillation) include atrioventricular block complete (n=3), angina pectoris (n=2), myocardial ischemia (n=2), and myocardial infarction (n=2); cCardiac events (grade ≥3) that occurred in >1 patient (other than atrial fibrillation) include acute myocardial infarction (n=3), cardiac failure (n=2), and myocardial infarction (n=2); dDefined as any serious or grade ≥3 hemorrhagic event, or any grade hemorrhagic event in the central nervous system.
Abbreviations
A = acalabrutinib
;AE = adverse event
;Clb = chlorambucil
;KM = Kaplan-Meier
;O = obinutuzumab
;SPM = second primary malignancies
;TEAE = treatment-emergency adverse event
References
2. In House Data, AstraZeneca Pharmaceuticals LP. DoF SD-2045-ALL-0112.
Document ID: 780f9b60-d375-4516-97d6-9ba58f025de4
Last updated: 17-April-2023
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