Trial Outcomes & Findings for Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies (NCT NCT03932331)

NCT ID: NCT03932331

Last Updated: 2026-01-29

Results Overview

An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A SAE is an AE occurring during any study phase, that fulfils 1 or more of the following criteria: death, life-threatening, in-participant hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, and an important medical event that may jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AEs leading to discontinuation of acalabrutinib were those with action taken was 'Drug Permanently Discontinued' for acalabrutinib.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 105 participants
• Primary outcome timeframe: From the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months.
• Results posted on: 2026-01-29

Participant Flow

This Phase I/II open-label study was conducted in participants with relapsed/refractory (R/R) mantle cell lymphoma (MCL), R/R chronic lymphocytic leukemia (CLL) or other B-cell malignancies at 20 study centers in China. The Phase II CLL results are reported for analysis with assessment until data cut-off (DCO) date of 18 December 2023. PD= Progressive disease.

This study was divided into 2 parts: Phase I portion (participants with R/R B-cell malignancies) and Phase II portion (participants with R/R MCL and R/R CLL). Study consists of screening period (28 days), treatment period until PD and a safety and survival follow-up period. A total of 105 unique participants were enrolled in the study, 12 participants in Phase I, 33 participants in Phase II MCL, 60 participants in Phase II CLL. One participant from Phase I entered Phase II MCL reporting group.

Participant milestones

Measure	Phase I Participants received single dose of acalabrutinib 100 milligram (mg) capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II MCL Participants with MCL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants with CLL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Overall Study STARTED	12	33	60
Overall Study Participants From Phase I Who Entered Phase II MCL	0	1	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	12	33	60

Reasons for withdrawal

Measure	Phase I Participants received single dose of acalabrutinib 100 milligram (mg) capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II MCL Participants with MCL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants with CLL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Overall Study Death	0	7	2
Overall Study Withdrawal by Subject	0	3	0
Overall Study Meet the point of final analysis for this cohort	8	23	0
Overall Study Progressive disease	3	0	0
Overall Study Lung infection	1	0	0
Overall Study Other	0	0	58

Baseline Characteristics

Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

Baseline characteristics by cohort

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II MCL n=33 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=35 Participants	22 Participants n=4328 Participants	37 Participants n=8687 Participants	66 Participants n=153 Participants
Age, Categorical >=65 years	5 Participants n=35 Participants	11 Participants n=4328 Participants	23 Participants n=8687 Participants	39 Participants n=153 Participants
Sex: Female, Male Female	7 Participants n=35 Participants	4 Participants n=4328 Participants	19 Participants n=8687 Participants	30 Participants n=153 Participants
Sex: Female, Male Male	5 Participants n=35 Participants	29 Participants n=4328 Participants	41 Participants n=8687 Participants	75 Participants n=153 Participants
Race/Ethnicity, Customized Asian	12 Participants n=35 Participants	33 Participants n=4328 Participants	60 Participants n=8687 Participants	105 Participants n=153 Participants

PRIMARY outcome

Timeframe: From the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months.

Population: The Safety analysis set included all participants who received at least 1 dose of acalabrutinib.

An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A SAE is an AE occurring during any study phase, that fulfils 1 or more of the following criteria: death, life-threatening, in-participant hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, and an important medical event that may jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AEs leading to discontinuation of acalabrutinib were those with action taken was 'Drug Permanently Discontinued' for acalabrutinib.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AE	12 Participants	—
Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any SAE	2 Participants	—
Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AE leading to discontinuation of Acalabrutinib	1 Participants	—
Phase I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AE with outcome death	0 Participants	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 0 Day 1

Population: The Pharmacokinetics (PK) analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the AUCinf of acalabrutinib and ACP-5862 in plasma. The AUCinf was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUCinf) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib Acalabrutinib	1351 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 47.99	—
Phase I: Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUCinf) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib ACP-5862	2421 hour*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 29.46	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8 and 12 hours postdose on Cycle 0 Day 1

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the AUC0-12 of acalabrutinib and ACP-5862 in plasma. The AUC0-12 was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Area Under the Plasma Concentration-Time Curve From Zero to 12 Hours (AUC0-12) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib Acalabrutinib	1310 h*ng/mL Geometric Coefficient of Variation 50.39	—
Phase I: Area Under the Plasma Concentration-Time Curve From Zero to 12 Hours (AUC0-12) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib ACP-5862	2008 h*ng/mL Geometric Coefficient of Variation 37.76	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 0 Day 1

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the AUClast of acalabrutinib and ACP-5862 in plasma. The AUClast was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Area Under the Plasma Concentration-Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUClast) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib Acalabrutinib	1343 h*ng/mL Geometric Coefficient of Variation 48.40	—
Phase I: Area Under the Plasma Concentration-Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUClast) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib ACP-5862	2270 h*ng/mL Geometric Coefficient of Variation 32.82	—

PRIMARY outcome

Timeframe: Single dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8 and 12 hours postdose on Cycle 0 Day 1; Multiple dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the Cmax of acalabrutinib and ACP-5862 in plasma. The Cmax was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Maximum Observed Plasma Drug Concentration (Cmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post single dose: Acalabrutinib	967.6 ng/mL Geometric Coefficient of Variation 59.52	—
Phase I: Maximum Observed Plasma Drug Concentration (Cmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post single dose: ACP-5862	628.1 ng/mL Geometric Coefficient of Variation 46.38	—
Phase I: Maximum Observed Plasma Drug Concentration (Cmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post multiple dose: Acalabrutinib	958.2 ng/mL Geometric Coefficient of Variation 60.99	—
Phase I: Maximum Observed Plasma Drug Concentration (Cmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post multiple dose: ACP-5862	710.0 ng/mL Geometric Coefficient of Variation 38.08	—

PRIMARY outcome

Timeframe: Single dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8 and 12 hours postdose on Cycle 0 Day 1; Multiple dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the tmax of acalabrutinib and ACP-5862 in plasma. The tmax was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Time to Reach Maximum Observed Concentration (Tmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post multiple dose: Acalabrutinib	0.50 hour Interval 0.27 to 2.03	—
Phase I: Time to Reach Maximum Observed Concentration (Tmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post multiple dose: ACP-5862	1.00 hour Interval 0.73 to 3.95	—
Phase I: Time to Reach Maximum Observed Concentration (Tmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post single dose: Acalabrutinib	0.50 hour Interval 0.48 to 1.02	—
Phase I: Time to Reach Maximum Observed Concentration (Tmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post single dose: ACP-5862	0.88 hour Interval 0.73 to 2.0	—

PRIMARY outcome

Timeframe: Single dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8 and 12 hours postdose on Cycle 0 Day 1; Multiple dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Urine samples were collected to determine the CL/F of acalabrutinib. The CL/F was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Apparent Total Body Clearance of Drug (CL/F) of Acalabrutinib Post Single and Multiple Dose of Acalabrutinib Post single dose	74.01 liter per hour Geometric Coefficient of Variation 36.77	—
Phase I: Apparent Total Body Clearance of Drug (CL/F) of Acalabrutinib Post Single and Multiple Dose of Acalabrutinib Post multiple dose	72.81 liter per hour Geometric Coefficient of Variation 45.25	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 0 Day 1

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the Vz/F of acalabrutinib in plasma. The Vz/F was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Apparent Volume of Distribution (Vz/F) of Acalabrutinib Post Single Dose of Acalabrutinib	171.3 liter Geometric Coefficient of Variation 105.5	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 0 Day 1

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the λz of acalabrutinib and ACP-5862 in plasma. The λz was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Terminal Elimination Rate Constant (λz) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib Acalabrutinib	0.43212 1/hour Geometric Coefficient of Variation 51.085	—
Phase I: Terminal Elimination Rate Constant (λz) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib ACP-5862	0.096102 1/hour Geometric Coefficient of Variation 19.036	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 0 Day 1

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the t1/2λz of acalabrutinib and ACP-5862 in plasma. The t1/2λz was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Terminal Phase Half-Life (t1/2λz) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib Acalabrutinib	1.604 hour Geometric Coefficient of Variation 76.21	—
Phase I: Terminal Phase Half-Life (t1/2λz) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib ACP-5862	7.213 hour Geometric Coefficient of Variation 28.03	—

PRIMARY outcome

Timeframe: Single dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8 and 12 hours postdose on Cycle 0 Day 1; Multiple dose: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the MRCmax of acalabrutinib and ACP-5862 in plasma. The MRCmax was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Metabolite/Parent Drug Cmax Ratio (MRCmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post single dose	0.6276 ratio Geometric Coefficient of Variation 37.87	—
Phase I: Metabolite/Parent Drug Cmax Ratio (MRCmax) of Acalabrutinib and ACP-5862 Post Single and Multiple Dose of Acalabrutinib Post multiple dose	0.7662 ratio Geometric Coefficient of Variation 43.08	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 0 Day 1

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the MRAUCinf of acalabrutinib in plasma. The MRAUCinf was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Metabolite/Parent Drug AUC Ratio (MRAUCinf) of Acalabrutinib and ACP-5862 Post Single Dose of Acalabrutinib	1.732 ratio Geometric Coefficient of Variation 31.55	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the AUCτ of acalabrutinib and ACP-5862 in plasma. The AUCτ was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Area Under the Plasma Concentration-Time Curve Across the Dosing Interval (AUCτ) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib ACP-5862	2707 h*ng/mL Geometric Coefficient of Variation 28.61	—
Phase I: Area Under the Plasma Concentration-Time Curve Across the Dosing Interval (AUCτ) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib Acalabrutinib	1373 h*ng/mL Geometric Coefficient of Variation 43.62	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the Cmin of acalabrutinib and ACP-5862 in plasma. The Cmin was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Minimum Observed Plasma Drug Concentration (Cmin) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib Acalabrutinib	2.443 ng/mL Geometric Coefficient of Variation 148.0	—
Phase I: Minimum Observed Plasma Drug Concentration (Cmin) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib ACP-5862	37.52 ng/mL Geometric Coefficient of Variation 37.58	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the MRAUCτ of acalabrutinib and ACP-5862 in plasma. The MRAUCτ was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Metabolite/Parent Drug AUCτ Ratio (MRAUCτ) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib	1.906 ratio Geometric Coefficient of Variation 33.26	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the TCP of acalabrutinib and ACP-5862 in plasma. The TCP in systemic exposure was calculated as AUCτ (steady state)/AUCinf (first dose). The TCP was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Temporal Change Parameter (TCP) in Systemic Exposure of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib Acalabrutinib	1.017 ratio Geometric Coefficient of Variation 37.57	—
Phase I: Temporal Change Parameter (TCP) in Systemic Exposure of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib ACP-5862	1.118 ratio Geometric Coefficient of Variation 17.15	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the Rac AUC of acalabrutinib and ACP-5862 in plasma. The Rac AUC was calculated as AUCτ (steady state)/AUCτ (first dose). The Rac AUC was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Accumulation Ratio of AUCτ (Rac AUC) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib Acalabrutinib	1.048 ratio Geometric Coefficient of Variation 37.97	—
Phase I: Accumulation Ratio of AUCτ (Rac AUC) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib ACP-5862	1.348 ratio Geometric Coefficient of Variation 41.64	—

PRIMARY outcome

Timeframe: Pre-dose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 24 and 48 hours postdose on Cycle 1 Day 8

Population: The PK analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the Rac Cmax of acalabrutinib and ACP-5862 in plasma. The Rac Cmax was calculated as Cmax (steady state)/Cmax (first dose). The Rac Cmax was determined using non-compartmental method.

Outcome measures

Measure	Phase I n=12 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Accumulation Ratio of Cmax (Rac Cmax) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib Acalabrutinib	0.8218 ratio Geometric Coefficient of Variation 59.99	—
Phase I: Accumulation Ratio of Cmax (Rac Cmax) of Acalabrutinib and ACP-5862 Post Multiple Dose of Acalabrutinib ACP-5862	1.130 ratio Geometric Coefficient of Variation 70.23	—

PRIMARY outcome

Timeframe: Response evaluations performed at the end of Cycles 2, 4 and 6; and then every 12 weeks +/- 7 days through Cycle 25, and then every 24 weeks +/- 7 days thereafter. Assessed until 18 December 2023.

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. One participant from Phase I rolled over to Phase II MCL reporting group.

The ORR [based on International workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria as assessed by the BICR] was defined as the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi), nodular partial response (nPR), and partial response (PR). The ORR and the corresponding 95% 2-sided confidence interval (CI) of ORR were presented based on Clopper-Pearson exact method.

Outcome measures

Measure	Phase I n=34 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR)	82.4 percentage of participants Interval 65.5 to 93.2	86.7 percentage of participants Interval 75.4 to 94.1

SECONDARY outcome

Timeframe: Response evaluations performed at the end of Cycles 2, 4 and 6; and then every 12 weeks +/- 7 days thereafter or more frequently at the investigator's discretion, approximately 25 months

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. Only participants with R/R CLL are analyzed in this outcome measure.

The BOR is best response a participant has had following first dose date but prior to starting any subsequent anticancer therapy up to and including progression or last evaluable assessment in absence of progression. The CR: No lymph nodes >=1.5 centimeters. The CRi: Participants who fulfill all criteria for CR but have a persistent anemia, thrombocytopenia or neutropenia apparently unrelated to CLL but related to drug toxicity. The nPR: Participants who were in a complete remission but bone marrow nodules can be identified histologically. The PR: Disease >=50% from baseline. Partial response with lymphocytosis (PRL): Presence of lymphocytosis plus >=50% reduction in lymphadenopathy and/or in spleen or liver enlargement plus 1 of PR criteria for platelets or hemoglobin must be met. Stable disease (SD): Change of -49% to +49% in lymph nodes. PD: Increase >=50% from baseline or from response.

Outcome measures

Measure	Phase I n=4 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL nPR	0 Participants	—
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL CR	0 Participants	—
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL CRi	0 Participants	—
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL PR	4 Participants	—
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL PRL	0 Participants	—
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL SD	0 Participants	—
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL PD	0 Participants	—
Phase I: Best Overall Response (BOR) Assessed by Investigator in Participants With R/R CLL Not evaluable	0 Participants	—

SECONDARY outcome

Timeframe: Response evaluations performed at the end of Cycles 2, 4 and 6; and then every 12 weeks +/- 7 days thereafter or more frequently at the investigator's discretion, approximately 25 months

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. Only participants with R/R MCL are analyzed in this outcome measure.

The BOR is best response a participant has had following first dose date but prior to starting any subsequent anticancer therapy up to and including progression or last evaluable assessment in absence of progression. CR: No lymph nodes >=1.5 centimeters. PR: Disease >=50% from baseline. SD: Change of -49% to +49% in lymph nodes. PD: Increase >=50% from baseline or from response.

Outcome measures

Measure	Phase I n=8 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase I: Best Overall Response Assessed by Investigator in Participants With R/R MCL SD	0 Participants	—
Phase I: Best Overall Response Assessed by Investigator in Participants With R/R MCL PD	3 Participants	—
Phase I: Best Overall Response Assessed by Investigator in Participants With R/R MCL CR	1 Participants	—
Phase I: Best Overall Response Assessed by Investigator in Participants With R/R MCL PR	4 Participants	—
Phase I: Best Overall Response Assessed by Investigator in Participants With R/R MCL Not evaluable	0 Participants	—

SECONDARY outcome

Timeframe: Response evaluations performed at the end of Cycles 2, 4 and 6; and then every 12 weeks +/- 7 days through Cycle 25, and then every 24 weeks +/- 7 days thereafter. Assessed until 18 December 2023.

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. One participant from Phase I rolled over to Phase II MCL reporting group.

The ORR (based on iwCLL 2018 criteria as assessed by the Investigator) was defined as the percentage of participants who achieved a CR, CRi, nPR, and PR. The ORR and the corresponding 95% 2-sided CI of ORR were presented based on Clopper-Pearson exact method.

Outcome measures

Measure	Phase I n=34 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II: ORR Assessed by Investigator	73.5 percentage of participants Interval 55.6 to 87.1	85.0 percentage of participants Interval 73.4 to 92.9

SECONDARY outcome

Timeframe: Response evaluations performed at the end of Cycles 2, 4 and 6; and then every 12 weeks +/- 7 days through Cycle 25, and then every 24 weeks +/- 7 days thereafter. Assessed until 18 December 2023.

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. Only participants who achieved PR or above were analyzed.

The DoR (based on iwCLL 2018 criteria as assessed by the BICR and Investigator) was defined as the interval from the first documentation of objective response to the earlier of the first documentation of objective PD or death from any cause. The DoR was calculated using Kaplan-Meier technique.

Outcome measures

Measure	Phase I n=28 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=52 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II: Duration of Response (DoR) Assessed by BICR and Investigator BICR Assessment	NA months Interval 6.4 to The DOR is not mature to report median and upper limit of inter-quartile range at time of analysis.	NA months Interval 25.0 to The DOR is not mature to report median and upper limit of inter-quartile range at time of analysis.
Phase II: Duration of Response (DoR) Assessed by BICR and Investigator Investigator Assessment	NA months Interval 11.2 to The DOR is not mature to report median and upper limit of inter-quartile range at time of analysis.	NA months Interval 26.38 to The DOR is not mature to report median and upper limit of inter-quartile range at time of analysis.

SECONDARY outcome

Timeframe: Response evaluations performed at the end of Cycles 2, 4 and 6; and then every 12 weeks +/- 7 days through Cycle 25, and then every 24 weeks +/- 7 days thereafter. Assessed until 18 December 2023.

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. One participant from Phase I rolled over to Phase II MCL reporting group.

The PFS (based on iwCLL 2018 criteria as assessed by the BICR and Investigator) was defined as the interval from the start of acalabrutinib therapy to the earlier of the first documentation of objective PD or death from any cause. The PFS was calculated using Kaplan-Meier technique.

Outcome measures

Measure	Phase I n=34 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II: Progression-Free Survival (PFS) Assessed by BICR and Investigator BICR Assessment	NA months Interval 5.55 to The PFS is not mature to report median and upper limit of 95% confidence interval at time of analysis.	NA months Interval 28.32 to The PFS is not mature to report median and upper limit of 95% confidence interval at time of analysis.
Phase II: Progression-Free Survival (PFS) Assessed by BICR and Investigator Investigator Assessment	NA months Interval 5.55 to The PFS is not mature to report median and upper limit of 95% confidence interval at time of analysis.	NA months Interval 30.62 to The PFS is not mature to report median and upper limit of 95% confidence interval at time of analysis.

SECONDARY outcome

Timeframe: Response evaluations performed at the end of Cycles 2, 4 and 6; and then every 12 weeks +/- 7 days through Cycle 25, and then every 24 weeks +/- 7 days thereafter. Assessed until 18 December 2023.

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. Only participants with response were analyzed.

The TTR (based on iwCLL 2018 criteria as assessed by the BICR and Investigator) was defined as the interval between the date of first dose and the date of initial documentation of a response.

Outcome measures

Measure	Phase I n=28 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=52 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II: Time to Response (TTR) Assessed by BICR and Investigator BICR Assessment	1.8 months Interval 1.6 to 3.7	5.06 months Interval 2.7 to 16.6
Phase II: Time to Response (TTR) Assessed by BICR and Investigator Investigator Assessment	1.9 months Interval 1.6 to 3.7	5.52 months Interval 2.7 to 22.2

SECONDARY outcome

Timeframe: Response evaluations performed every 12 weeks +/- 7 days through Cycle 25, and then every 24 weeks +/- 7 days thereafter. Assessed until 18 December 2023.

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment.

The TTNT was defined as the interval from the start of acalabrutinib therapy to institution of non-protocol specified anticancer treatment for CLL or death due to any cause, whichever came first. The TTNT was calculated using Kaplan-Meier technique.

Outcome measures

Measure	Phase I n=60 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II CLL Only: Time to Next Treatment (TTNT)	NA months The TTNT is not mature to report median and 95% confidence interval at time of analysis.	—

SECONDARY outcome

Timeframe: At screening (-28 days) and end of treatment visit. Assessed until 18 December 2023.

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment.

The MRD negative rate was defined as the percentage of participants with MRD-negativity (<1 CLL cell per 10000 leukocytes) measured in the peripheral blood by flow cytometry.

Outcome measures

Measure	Phase I n=60 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II CLL Only: Percentage of Participants With Minimal Residual Disease (MRD) Negativity	0 percentage of participants	—

SECONDARY outcome

Timeframe: From the first dose administration up to Month 6

Population: Tumour response analysis set included all participants who received at least 1 dose of acalabrutinib with an available baseline tumour assessment. One participant from Phase I rolled over to Phase II MCL reporting group.

The OS was defined as the interval from the start of acalabrutinib therapy to death from any cause. The OS was calculated using Kaplan-Meier technique.

Outcome measures

Measure	Phase I n=34 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II: Percentage of Participants With Overall Survival (OS) at Month 6	NA percentage of participants The OS is not mature to report median and 95% confidence interval at time of analysis.	96.7 percentage of participants Interval 87.3 to 99.2

SECONDARY outcome

Timeframe: At 1, 2 and 4 hours post-dose on Day 8, 15 and 22 of Cycle 1

Population: The pharmacokinetics (PK) analysis set included all participants who received at least 1 dose of acalabrutinib with reportable acalabrutinib plasma concentration and PK parameter data with no important protocol deviations that may impact PK.

Blood samples were collected to determine the plasma concentration of acalabrutinib.

Outcome measures

Measure	Phase I n=33 Participants Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 Participants Participants received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 8: 1 hour	157.3 nanogram per milliliter Geometric Coefficient of Variation 103.6	238.7 nanogram per milliliter Geometric Coefficient of Variation 288.2
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 8: 2 hour	155.0 nanogram per milliliter Geometric Coefficient of Variation 70.33	187.2 nanogram per milliliter Geometric Coefficient of Variation 111.4
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 8: 4 hour	77.06 nanogram per milliliter Geometric Coefficient of Variation 94.19	58.73 nanogram per milliliter Geometric Coefficient of Variation 115.4
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 15: 2 hour	178.9 nanogram per milliliter Geometric Coefficient of Variation 70.41	195.7 nanogram per milliliter Geometric Coefficient of Variation 152.2
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 15: 4 hour	61.31 nanogram per milliliter Geometric Coefficient of Variation 75.60	49.96 nanogram per milliliter Geometric Coefficient of Variation 162.4
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 22: 1 hour	196.3 nanogram per milliliter Geometric Coefficient of Variation 93.17	—
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 22: 2 hour	121.3 nanogram per milliliter Geometric Coefficient of Variation 87.67	—
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 22: 4 hour	100.8 nanogram per milliliter Geometric Coefficient of Variation 162.3	—
Phase II: Plasma Concentration of Acalabrutinib Cycle 1 Day 15: 1 hour	160.3 nanogram per milliliter Geometric Coefficient of Variation 90.00	206.6 nanogram per milliliter Geometric Coefficient of Variation 354.3

Adverse Events

Phase I

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Phase II MCL

Serious events: 6 serious events

Other events: 28 other events

Deaths: 7 deaths

Phase II CLL

Serious events: 21 serious events

Other events: 56 other events

Deaths: 2 deaths

Serious adverse events

Measure	Phase I n=12 participants at risk Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II MCL n=34 participants at risk Participants with MCL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 participants at risk Participants with CLL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Pneumonia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Pneumonia fungal	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Cardiac arrest	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Coronary artery disease	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Neutrophil count decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations White blood cell count decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Paraneoplastic pemphigus	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Aplastic anaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Febrile neutropenia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Inguinal hernia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Hernia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Multiple organ dysfunction syndrome	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Pelvic mass	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Anal abscess	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Covid-19	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	10.0% 6/60 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Covid-19 pneumonia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.3% 5/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Gastrointestinal infection	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Herpes zoster	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.

Other adverse events

Measure	Phase I n=12 participants at risk Participants received single dose of acalabrutinib 100 mg capsule orally on Day 1 Cycle 0 and followed by 2 days washout period and then received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II MCL n=34 participants at risk Participants with MCL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.	Phase II CLL n=60 participants at risk Participants with CLL received acalabrutinib 100 mg capsule orally twice daily in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 2/12 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	10.0% 6/60 • Number of events 8 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Mastoiditis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Nasal herpes	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Pelvic inflammatory disease	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Periodontitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Pharyngitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Pneumonia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	20.0% 12/60 • Number of events 17 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Pneumonia fungal	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Pneumonia viral	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Rash pustular	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Angina pectoris	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Skin infection	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Suspected covid-19	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Upper respiratory tract infection	25.0% 3/12 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	23.5% 8/34 • Number of events 9 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	18.3% 11/60 • Number of events 15 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Urethritis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Urinary tract infection	16.7% 2/12 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 9 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Injury, poisoning and procedural complications Foot fracture	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Injury, poisoning and procedural complications Ligament sprain	16.7% 2/12 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Injury, poisoning and procedural complications Post procedural haemorrhage	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Arrhythmia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Alanine aminotransferase increased	16.7% 2/12 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	17.6% 6/34 • Number of events 11 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 10 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Alpha hydroxybutyrate dehydrogenase increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	20.6% 7/34 • Number of events 9 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 8 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Band neutrophil count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Basophil count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Beta 2 microglobulin increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Bilirubin conjugated increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood albumin decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood alkaline phosphatase increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood bicarbonate increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood bilirubin increased	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	17.6% 6/34 • Number of events 14 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.3% 5/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood cholesterol increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood creatinine increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood fibrinogen decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood fibrinogen increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood glucose increased	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood immunoglobulin a decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood immunoglobulin g decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood immunoglobulin g increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Atrioventricular block first degree	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood immunoglobulin m decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood immunoglobulin m increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood lactate dehydrogenase increased	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.3% 5/60 • Number of events 9 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood magnesium increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood phosphorus decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood phosphorus increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood potassium decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood sodium increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood triglycerides increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood urea increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Bundle branch block right	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood uric acid increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.3% 5/60 • Number of events 7 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Blood urine present	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations C-reactive protein increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Cd19 lymphocytes decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Cd19 lymphocytes increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Cd4 lymphocytes increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Cd8 lymphocytes increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Cell marker decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Complement factor c3 decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Complement factor c4 increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram p wave abnormal	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram pr shortened	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram q waves	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram qrs complex abnormal	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram qt prolonged	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram st segment abnormal	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram st segment depression	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram st-t change	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram st-t segment abnormal	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram t wave abnormal	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Cardiac failure	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Electrocardiogram high voltage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Eosinophil count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Gamma-glutamyltransferase increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Globulins decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 9 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Glucose urine present	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Haematocrit decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	15.0% 9/60 • Number of events 10 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Haemoglobin decreased	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	23.3% 14/60 • Number of events 20 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Helicobacter test positive	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Hepatitis b dna increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Hepatitis b core antibody positive	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Conduction disorder	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations High density lipoprotein decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations High density lipoprotein increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations International normalised ratio increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Lipoprotein increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Low density lipoprotein increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Lymphocyte count decreased	16.7% 2/12 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Lymphocyte count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	23.5% 8/34 • Number of events 9 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	10.0% 6/60 • Number of events 12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Lymphocyte percentage increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Monocyte count decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Monocyte count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Natural killer cell count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Neutrophil count decreased	33.3% 4/12 • Number of events 8 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	20.6% 7/34 • Number of events 10 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	46.7% 28/60 • Number of events 48 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Neutrophil count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Non-high-density lipoprotein cholesterol increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Platelet count decreased	33.3% 4/12 • Number of events 7 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	41.2% 14/34 • Number of events 19 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	40.0% 24/60 • Number of events 33 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Protein total decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 9 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Protein urine present	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Prothrombin level increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Prothrombin time prolonged	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Qrs axis abnormal	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Anaemia	33.3% 4/12 • Number of events 11 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	23.5% 8/34 • Number of events 8 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	23.3% 14/60 • Number of events 20 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Defect conduction intraventricular	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Red blood cell count decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 10 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Red blood cells urine positive	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Sars-cov-2 test positive	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations T-lymphocyte count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Urinary occult blood positive	16.7% 2/12 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Weight decreased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations Weight increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations White blood cell count decreased	41.7% 5/12 • Number of events 7 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 7 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations White blood cell count increased	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Investigations White blood cells urine positive	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Palpitations	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hyperglycaemia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hyperlipidaemia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 7 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	11.8% 4/34 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hyperuricaemia	33.3% 4/12 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	14.7% 5/34 • Number of events 11 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 16 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Pericardial effusion	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypokalaemia	16.7% 2/12 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	14.7% 5/34 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 8 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hyponatraemia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Hypoproteinaemia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Magnesium metabolism disorder	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Metabolism and nutrition disorders Malnutrition	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Sinus bradycardia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Sinus tachycardia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Nervous system disorders Cerebral infarction	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Nervous system disorders Dizziness	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 7 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Nervous system disorders Dysgeusia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Nervous system disorders Headache	25.0% 3/12 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	20.6% 7/34 • Number of events 16 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	16.7% 10/60 • Number of events 10 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Nervous system disorders Hypoaesthesia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Psychiatric disorders Insomnia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Renal and urinary disorders Haematuria	25.0% 3/12 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Renal and urinary disorders Oliguria	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Supraventricular extrasystoles	16.7% 2/12 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Renal and urinary disorders Proteinuria	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Renal and urinary disorders Renal impairment	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Renal and urinary disorders Ureterolithiasis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Reproductive system and breast disorders Gynaecomastia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Reproductive system and breast disorders Scrotal inflammation	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Reproductive system and breast disorders Vulvovaginal inflammation	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Tachycardia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Nasal mucosal erosion	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Ventricular arrhythmia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Small airways disease	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Respiratory, thoracic and mediastinal disorders Thoracic haemorrhage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Alopecia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Ventricular extrasystoles	16.7% 2/12 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Purpura	33.3% 4/12 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	17.6% 6/34 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 11 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Skin hypopigmentation	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Ventricular hypertrophy	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Skin and subcutaneous tissue disorders Urticaria	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Vascular disorders Haematoma	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Vascular disorders Haemorrhage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Vascular disorders Hypotension	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Vascular disorders Peripheral venous disease	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Cardiac disorders Wandering pacemaker	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Ear and labyrinth disorders Deafness	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Ear and labyrinth disorders Otolithiasis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Ear and labyrinth disorders Tinnitus	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Endocrine disorders Thyroid mass	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Eye disorders Cataract	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Eye disorders Conjunctival haemorrhage	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Eye disorders Dacryostenosis acquired	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Eye disorders Dry eye	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Eye disorders Eczema eyelids	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Eye disorders Eyelid function disorder	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Eye disorders Retinal haemorrhage	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Abdominal wall haemorrhage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Abnormal faeces	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Ascites	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Constipation	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Hypoglobulinaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Dental caries	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	17.6% 6/34 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	15.0% 9/60 • Number of events 11 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Eructation	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Gingival bleeding	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Haemorrhoids	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Loose tooth	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	11.8% 4/34 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 4 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Mouth ulceration	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Rectal prolapse	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Toothache	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.3% 5/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Asthenia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Chest discomfort	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Face oedema	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Fatigue	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	14.7% 5/34 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.3% 5/60 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Leukopenia	8.3% 1/12 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.8% 3/34 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Influenza like illness	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Oedema peripheral	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	14.7% 5/34 • Number of events 7 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Pain	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Peripheral swelling	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
General disorders Pyrexia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	13.3% 8/60 • Number of events 8 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Hepatobiliary disorders Hepatic function abnormal	16.7% 2/12 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	6.7% 4/60 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Hepatobiliary disorders Liver injury	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Bronchitis	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.0% 3/60 • Number of events 3 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Covid-19	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	26.7% 16/60 • Number of events 19 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Covid-19 pneumonia	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	8.3% 5/60 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Conjunctivitis	8.3% 1/12 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Coronavirus infection	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Dermatophytosis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Eye infection	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Folliculitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Blood and lymphatic system disorders Neutropenia	25.0% 3/12 • Number of events 5 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	5.9% 2/34 • Number of events 6 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Fungal infection	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Gastroenteritis shigella	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Gastroenteritis viral	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Gingivitis	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Hepatitis b reactivation	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Herpes virus infection	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/60 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Herpes zoster	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	2.9% 1/34 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	3.3% 2/60 • Number of events 2 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Influenza	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.
Infections and infestations Lymph gland infection	0.00% 0/12 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	0.00% 0/34 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.	1.7% 1/60 • Number of events 1 • Phase I and Phase II MCL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 25 months. Phase II CLL: Treatment-emergent adverse events and all-cause mortality were reported from the first dose administration up to 30 days following the date of last dose of study treatment, approximately 41 months. Assessed until DCO 18 December 2023. The Safety analysis set included all participants who received at least 1 dose of acalabrutinib. Phase I and Phase II MCL: MedDRA 24.1.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place