Trial Outcomes & Findings for A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP) (NCT NCT03395210)

Last Updated: 2025-11-14

Results Overview

The percentage of participants who achieved 2 or more consecutive platelet counts, separated by at least 5 days, of \>=50,000/ microliter (μL) and an increase of platelet count of \>=20,000/μL from baseline, by starting dose level and overall, without use of rescue medication in the 4 weeks prior to the latest elevated platelet count. 95% confidence interval (CI) was based on the Clopper-Pearson method. The average of the 2 screening results and the Cycle 1 Day 1 result were used as the baseline value.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

Up to 24 Weeks

Results posted on

2025-11-14

Participant Flow

The study was conducted at 31 active centers in 8 countries. As prespecified in statistical analysis plan (SAP), Part A results were presented by either of the of the treatment group labels: Starting dose level (each participant was assigned to only one of the groups), dose level (dose received during the defined period. As most patients received more than one dose, a given patient could be assigned to multiple dose levels) and overall.

A total of 60 participants in Part A and 26 participants in Part B were enrolled in the study. The results are presented up to primary completion date 31 January 2023.

Participant milestones

Participant milestones
Measure	Part A: Starting Dose 200 mg QD Participants received rilzabrutinib 200 milligrams (mg) orally once daily (QD) as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg twice daily (BID) (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 400 mg QD Participants received rilzabrutinib 400 mg orally QD as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg BID (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 300 mg BID Participants received rilzabrutinib 300 mg orally BID as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg BID (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 400 mg BID Participants received rilzabrutinib 400 mg orally BID as starting dose from Day 1 to 24 weeks, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.
Overall Study STARTED	9	1	5	45	26
Overall Study COMPLETED	4	0	0	15	4
Overall Study NOT COMPLETED	5	1	5	30	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Starting Dose 200 mg QD Participants received rilzabrutinib 200 milligrams (mg) orally once daily (QD) as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg twice daily (BID) (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 400 mg QD Participants received rilzabrutinib 400 mg orally QD as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg BID (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 300 mg BID Participants received rilzabrutinib 300 mg orally BID as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg BID (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 400 mg BID Participants received rilzabrutinib 400 mg orally BID as starting dose from Day 1 to 24 weeks, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.
Overall Study Other	0	0	0	0	1
Overall Study Participant Uncooperative or Noncompliant	0	0	0	0	1
Overall Study Adverse Event	1	0	2	4	3
Overall Study Need of Rescue Medication	1	0	1	4	0
Overall Study Lack of Response	0	0	0	5	5
Overall Study Participant was Erroneously Enrolled in the Study	1	0	0	0	1
Overall Study Participant Decision	1	1	0	4	0
Overall Study Ongoing at the Time of Primary Completion Date	1	0	2	13	11

Baseline Characteristics

A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Starting Dose 200 mg QD n=9 Participants Participants received rilzabrutinib 200 mg orally QD as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg BID (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 400 mg QD n=1 Participants Participants received rilzabrutinib 400 mg orally QD as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg BID (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 300 mg BID n=5 Participants Participants received rilzabrutinib 300 mg orally BID as starting dose from Day 1 to 4 weeks. Participants were allowed to up-titrate the dose levels unless withdrawn, had a platelet response to current dose level, or the next dose level had been determined to be ineligible for further enrollment every 4 weeks up to the maximum allowed 400 mg BID (800 mg/day) over 24 weeks of treatment period.	Part A: Starting Dose 400 mg BID n=45 Participants Participants received rilzabrutinib 400 mg orally BID as starting dose from Day 1 to 24 weeks, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=26 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Total n=86 Participants Total of all reporting groups
Age, Customized <65 years	8 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants	38 Participants n=45 Participants	19 Participants n=44 Participants	71 Participants n=45 Participants
Age, Customized >= 65 years	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	7 Participants n=45 Participants	7 Participants n=44 Participants	15 Participants n=45 Participants
Sex: Female, Male Female	4 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants	27 Participants n=45 Participants	16 Participants n=44 Participants	50 Participants n=45 Participants
Sex: Female, Male Male	5 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants	18 Participants n=45 Participants	10 Participants n=44 Participants	36 Participants n=45 Participants
Race/Ethnicity, Customized White	9 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants	39 Participants n=45 Participants	21 Participants n=44 Participants	75 Participants n=45 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=45 Participants
Race/Ethnicity, Customized Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants	4 Participants n=44 Participants	6 Participants n=45 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants	0 Participants n=44 Participants	1 Participants n=45 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=45 Participants
Race/Ethnicity, Customized Other	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	3 Participants n=45 Participants	1 Participants n=44 Participants	4 Participants n=45 Participants

PRIMARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all participants who had enrolled into the study. It was prespecified (SAP), data was analyzed by overall and starting dose level.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=5 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=45 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=1 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=60 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Percentage of Participants Who Achieved 2 or More Consecutive Platelet Counts by Starting Dose Level and Overall	40.0 percentage of participants Interval 5.27 to 85.34	40.0 percentage of participants Interval 25.7 to 55.67	44.4 percentage of participants Interval 13.7 to 78.8	0.0 percentage of participants Interval 0.0 to 97.5	40.0 percentage of participants Interval 27.56 to 53.46

PRIMARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all enrolled participants.

The percentage of participants who achieved platelet counts \>=50,000/μL on at least 8 out of the last 12 weeks of the 24-week treatment period without the use of rescue medication after 10 weeks of active treatment. 95% CI was based on the Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=26 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Percentage of Participants Who Achieved Platelet Counts >=50,000/μL	—	—	34.6 percentage of participants Interval 17.21 to 55.67	—	—

PRIMARY outcome

Timeframe: From first dose of rilzabrutinib (Day 1) up to last dose + 1 (up to 294 days)

Population: Safety population consisted of all participants who received at least 1 dose of rilzabrutinib. It was prespecified (SAP), data was analyzed by overall and dose level and participants could be classified into multiple dose levels.

Adverse event (AE): any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of rilzabrutinib, whether or not considered related to rilzabrutinib. TEAEs: AEs that developed or worsened or became serious on or after the first dose administration of rilzabrutinib (Day 1). Any TEAEs are considered treatment-related TEAEs as per Investigator's evaluation of participant's circumstances surrounding the event, and an evaluation of any potential alternative causes to determine whether an TEAE can be considered as related to the rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=12 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=52 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=8 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=60 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Related Treatment-Emergent Adverse Events TEAEs	5 Participants	44 Participants	3 Participants	3 Participants	48 Participants
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Related Treatment-Emergent Adverse Events Treatment related TEAEs	2 Participants	29 Participants	2 Participants	2 Participants	31 Participants

PRIMARY outcome

Timeframe: From first dose of rilzabrutinib (Day 1) up to last dose + 1 (approximately 170 days)

Population: Safety population consisted of all participants who had taken rilzabrutinib, regardless of the amount administered.

AE any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of rilzabrutinib, whether or not considered related to rilzabrutinib. TEAEs: AEs that developed or worsened or became serious during the treatment-emergent period, defined as any time after the first dose administration of rilzabrutinib (Day 1). Any TEAEs are considered treatment-related TEAEs as per Investigator's evaluation of participant's circumstances surrounding the event, and an evaluation of any potential alternative causes to determine whether an TEAE can be considered as related to rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=26 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Number of Participants With Treatment-Emergent Adverse Events and Treatment Related Treatment-Emergent Adverse Events TEAEs	—	—	22 Participants	—	—
Part B: Number of Participants With Treatment-Emergent Adverse Events and Treatment Related Treatment-Emergent Adverse Events Treatment related TEAEs	—	—	16 Participants	—	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all participants who had enrolled into the study. Only participants with data collected at specified timepoints are reported. It was prespecified (SAP), data was analyzed by overall and starting dose level.

The percentage of weeks in which participants achieved platelet counts \>=50,000/μL in the treatment period are summarized here.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=5 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=45 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=8 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=1 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=59 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Percentage of Weeks With Platelet Counts >=50,000/μL by Starting Dose Level and Overall	39.58 percentage of weeks Standard Deviation 41.30	28.14 percentage of weeks Standard Deviation 36.41	27.92 percentage of weeks Standard Deviation 29.42	0.00 percentage of weeks Standard Deviation NA Standard deviation (SD) cannot be calculated for a single participant.	28.60 percentage of weeks Standard Deviation 35.39

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all participants who had enrolled into the study. It was prespecified (SAP), data was analyzed by overall and starting dose level.

The percentage of participants who had at least 4 out of the final 8 platelet counts \>=50,000/μL are summarized here. The final 8 scheduled platelet counts are the measurements performed in the last 8 weeks of rilzabrutinib (depending on treatment duration, not necessarily from Week 19 to Week 24) in the treatment period. 95% CI was based on the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=5 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=45 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=1 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=60 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Percentage of Participants With 4 Out of the Final 8 Platelet Counts >=50,000/μL by Starting Dose Level and Overall	40.0 percentage of participants Interval 5.27 to 85.34	31.1 percentage of participants Interval 18.17 to 46.65	11.1 percentage of participants Interval 0.28 to 48.25	0.0 percentage of participants Interval 0.0 to 97.5	28.3 percentage of participants Interval 17.45 to 41.44

SECONDARY outcome

Timeframe: Baseline and up to 24 Weeks

Population: ITT population consisted of all participants who had enrolled into the study. It was prespecified (SAP), data was analyzed by overall and dose level and participants can be classified into multiple dose levels. Only participants with data who had more than 4 weeks of rilzabrutinib within a dose level are reported in each dose level. Participants with more than 4 weeks of study drug across all dose levels are included in overall.

Average of post Day 1 platelet count is equivalent to average of (average of each participant's post-Day 1 platelet counts), included platelet counts up to 1 day after the date of last dose of rilzabrutinib and excluded platelet counts on or after date of rescue, if applicable. The average of the 2 screening results and the Cycle 1 Day 1 result measured on different date were used as the baseline value.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=6 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=45 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=3 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=1 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=54 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Change From Baseline to the Average of Post Day 1 Platelet Counts by Dose Level and Overall	37.05 platelets x10^9/Liter (L) Standard Deviation 29.10	29.92 platelets x10^9/Liter (L) Standard Deviation 41.70	6.92 platelets x10^9/Liter (L) Standard Deviation 22.52	68.10 platelets x10^9/Liter (L) Standard Deviation NA SD cannot be calculated for a single participant.	28.61 platelets x10^9/Liter (L) Standard Deviation 39.57

SECONDARY outcome

Timeframe: Up to 24 Weeks

The number of weeks in which participant achieved platelet counts \>=50,000/μL in the treatment period are summarized here. The number of weeks is based on the number of scheduled weekly assessments, by study day.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=5 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=45 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=8 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=1 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=59 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Number of Weeks With Platelet Counts >=50,000/μL by Starting Dose Level and Overall	10.2 weeks Standard Deviation 12.0	5.7 weeks Standard Deviation 8.1	5.9 weeks Standard Deviation 7.8	0.0 weeks Standard Deviation NA SD cannot be calculated for a single participant.	6.0 weeks Standard Deviation 8.3

SECONDARY outcome

Timeframe: Up to 24 Weeks

The number of weeks in which participant achieved platelet counts \>=30,000/μL in the treatment period are summarized here. The number of weeks is based on the number of scheduled weekly assessments, by study day.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=5 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=45 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=8 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=1 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=59 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Number of Weeks With Platelet Counts >=30,000/μL by Starting Dose Level and Overall	14.0 weeks Standard Deviation 14.1	8.8 weeks Standard Deviation 9.2	8.4 weeks Standard Deviation 11.2	0.0 weeks Standard Deviation NA SD cannot be calculated for a single participant.	9.0 weeks Standard Deviation 9.8

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all participants who had enrolled into the study. It was prespecified (protocol and SAP) that data will be analyzed for overall across all dose levels, so combined data reported here. Only participants with data collected at specified timepoints are reported.

Time to first platelet count \>=50,000/μL during the treatment period in days was calculated as: (date of first occurrence of platelet count \>=50,000/μL - date of first rilzabrutinib dosing) +1.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=30 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Time to First Platelet Count >=50,000/μL Across All Dose Levels	—	—	27.4 days Standard Deviation 31.86	—	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all enrolled participants.

The number of weeks in which participant achieved platelet counts with thresholds as: \>=50,000/μL or \>=30,000/μL and doubling the baseline in the absence of rescue therapy (platelet counts will be censored for 4 weeks after the use of rescue medication, if given) are summarized here. Baseline is defined as the average of 3 platelet counts: 2 qualified screening platelet counts collected in electronic case report form (eCRF) and Week 1 (study day 1) platelet count.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=26 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Number of Weeks With Platelet Counts >= 50,000/μL or >= 30,000/μL and Doubling the Baseline	—	—	9.3 weeks Standard Deviation 10.1	—	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all enrolled participants.

Percentage of participants who achieved 2 or more consecutive platelet counts, separated by at least 5 days, of \>=50,000/μL and an increase of platelet count of \>=20,000/μL from baseline without use of rescue medication in the 4 weeks prior to the latest elevated platelet count are summarized here. Baseline is defined as the average of 3 platelet counts: 2 qualified screening platelet counts collected in eCRF and Week 1 (study day 1) platelet count. 95% CI was based on the Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=26 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Percentage of Participants Who Achieved 2 or More Consecutive Platelet Counts	—	—	42.3 percentage of participants Interval 23.35 to 63.08	—	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all enrolled participants.

The number of weeks in which participant achieved platelet counts \>=30,000/μL and doubling the baseline in the absence of rescue therapy (platelet counts will be censored for 4 weeks after the use of rescue medication, if given) are summarized here. Baseline is defined as the average of 3 platelet counts: 2 qualified screening platelet counts collected in eCRF and Week 1 (study day 1) platelet count.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=26 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Number of Weeks With Platelet Counts >=30,000/μL and Doubling the Baseline	—	—	9.3 weeks Standard Deviation 10.1	—	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: ITT population consisted of all enrolled participants.

Rescue medication is defined as any therapy used to rescue a participant (1 of intravenous immunoglobulin \[IVIG\], high-dose steroids, platelet infusion or anti-D immunoglobulin infusion). Percentage of participants who received rescue medication are summarized here. 95% CI was based on the Clopper-Pearson exact method.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=26 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Percentage of Participants Who Received Rescue Medication	—	—	11.5 percentage of participants Interval 2.45 to 30.15	—	—

SECONDARY outcome

Timeframe: Baseline and up to 24 weeks

Population: ITT population consisted of all enrolled participants. Only participants with data collected at specified timepoints are reported.

The IBLS is a bleeding assessment score. IBLS comprises of 11 sites for female and 10 sites for male, and each site is scored from 0 (none) to 2 (marked bleeding). The total overall score ranges from 0-22, with higher scores indicating higher presence of marked bleeding. For each participant, an IBLS score at each visit was calculated by taking the average across 11 items (10 for male and postmenopausal women) at 9 anatomical sites (8 for male and postmenopausal women). For each participant, a mean IBLS score was also calculated by taking the average across all post-baseline visits during the 24-week treatment period. IBLS average value ranges from 0 to 2. The smaller the IBLS average value is, the healthier the participants are. For change from baseline, negative value indicates an improvement. The baseline value is defined as the last available value before the first dose rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=24 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Change From Baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS)	—	—	-0.07 score on a scale Standard Deviation 0.13	—	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Safety population consisted of all participants who received at least 1 dose of rilzabrutinib. Participants are classified into different dose levels according to the dose received at the start of rescue medication. A given participant can be classified into multiple dose levels. It was prespecified (SAP), data was analyzed by overall and dose level.

Rescue medication is defined as any therapy used to rescue a participant (1 of IVIG, high-dose steroids, platelet infusion or anti-D immunoglobulin infusion). The percentage of participants who received rescue medication for each dose level and overall are summarized here. 95% CI was based on the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=12 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=52 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=8 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=60 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Percentage of Participants Who Received Rescue Medication by Dose Levels and Overall	8.3 percentage of participants Interval 0.21 to 38.48	9.6 percentage of participants Interval 3.2 to 21.03	11.1 percentage of participants Interval 0.28 to 48.25	0.0 percentage of participants Interval 0.0 to 36.94	11.7 percentage of participants Interval 4.82 to 22.57

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Safety population consisted of all participants who received at least 1 dose of rilzabrutinib. Participants are classified into different dose levels according to the dose received at the start of the bleeding event. A given participant can be classified into multiple dose levels. It was prespecified (SAP), data was analyzed by overall and dose level.

The percentage of participants with intensity grade 2 or higher bleeding event are summarized for each dose level and overall. The TEAEs with standardized medical dictionary for regulatory activities (MedDRA) query (SMQ) hemorrhages were medically determined for analysis of bleeding events. 95% CI was based on the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=12 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=52 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=8 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=60 Participants All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Percentage of Participants With Grade 2 or Higher Bleeding Event by Dose Level and Overall	8.3 percentage of participants Interval 0.21 to 38.48	17.3 percentage of participants Interval 8.23 to 30.33	0.0 percentage of participants Interval 0.0 to 33.63	0.0 percentage of participants Interval 0.0 to 36.94	16.7 percentage of participants Interval 8.29 to 28.52

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Safety population consisted of all participants who received at least 1 dose of rilzabrutinib. It was prespecified (SAP), data was analyzed by dose level and participants can be classified into multiple dose levels.

The ITP-BAT scale comprises of 11 grades from 0 (none) to 2 (marked bleeding), with higher scores indicating higher presence of marked bleeding, assessed at 9 anatomical sites (skin, oral, epistaxis, gastrointestinal \[GI\], urinary, gynecological \[GYN\], pulmonary, intracranial hemorrhage \[HEM\], subconjunctival HEM) by history over the previous week (Hx). In addition, 2 sites (skin and oral), were also assessed by physical examination (PE). The 'worst ever' bleeding experienced at each site was graded using the same system. Here, 0 indicates none; 1 indicates 1-5 bruises and/or scattered petechiae and 2 indicates \>5 bruises with size \>2 centimeter (cm) and/or diffuse petechiae. Each participant summed up the transformed scores across all 11 sites per visit assessment. The total overall score ranges from 0-22 with the higher score indicating worst outcome.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=12 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=52 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=8 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (PE): Score 0	6 Participants	32 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (PE): Score 1	3 Participants	12 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (PE): Score 2	0 Participants	6 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (PE): Scoring not done/missing	3 Participants	2 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (PE): Score 0	9 Participants	42 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (PE): Score 1	0 Participants	4 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (PE): Score 2	0 Participants	4 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (PE): Scoring not done/missing	3 Participants	2 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (Hx): Score 0	5 Participants	34 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (Hx): Score 1	4 Participants	11 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (Hx): Score 2	0 Participants	5 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Skin (Hx): Scoring not done/missing	3 Participants	2 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (Hx): Score 0	9 Participants	43 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (Hx): Score 1	0 Participants	2 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (Hx): Score 2	0 Participants	5 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Oral (Hx): Scoring not done/missing	3 Participants	2 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Epistaxis: Score 0	9 Participants	49 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Epistaxis: Score 1	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Epistaxis: Score 2	0 Participants	1 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Epistaxis: Scoring not done/missing	3 Participants	2 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GI: Score 0	10 Participants	49 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GI: Score 1	0 Participants	1 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GI: Score 2	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GI: Scoring not done/missing	2 Participants	2 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Urinary: Score 0	9 Participants	48 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Urinary: Score 1	0 Participants	2 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Urinary: Score 2	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Urinary: Scoring not done/missing	3 Participants	2 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GYN: Score 0	4 Participants	22 Participants	1 Participants	1 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GYN: Score 1	0 Participants	1 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GYN: Score 2	0 Participants	1 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level GYN: Scoring not done/missing	8 Participants	28 Participants	8 Participants	7 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Pulmonary: Score 0	8 Participants	49 Participants	6 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Pulmonary: Score 1	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Pulmonary: Score 2	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Pulmonary: Scoring not done/missing	4 Participants	3 Participants	3 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Intracranial HEM: Score 0	8 Participants	49 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Intracranial HEM: Score 1	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Intracranial HEM: Score 2	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Intracranial HEM: Scoring not done/missing	4 Participants	3 Participants	2 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Subconjunctival HEM: Score 0	8 Participants	50 Participants	7 Participants	8 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Subconjunctival HEM: Score 1	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Subconjunctival HEM: Score 2	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Idiopathic Thrombocytopenic Purpura/Immune Thrombocytopenia (ITP) Bleeding Assessment Tool (ITP-BAT) Scale by Dose Level Subconjunctival HEM: Scoring not done/missing	4 Participants	2 Participants	2 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 3, and 5 (each cycle 28 days)

Population: ITT population consisted of all participants who had enrolled into the study. It was prespecified (SAP), data was analyzed based on frequent sampling on Day 1 of a new, higher dosing level and reported by dose. Only participants who received rilzabrutinib with data collected at specified timepoints are reported.

Plasma samples were collected at specified timepoints to determine Cmax of rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=9 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=43 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=7 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Maximum Observed Plasma Concentration (Cmax) of Rilzabrutinib Cycle 5 Day 1	—	447 nanogram per milliliter (ng/mL) Standard Deviation 67.2	—	—	—
Part A: Maximum Observed Plasma Concentration (Cmax) of Rilzabrutinib Cycle 1 Day 1	287 nanogram per milliliter (ng/mL) Standard Deviation 149	273 nanogram per milliliter (ng/mL) Standard Deviation 203	154 nanogram per milliliter (ng/mL) Standard Deviation 117	—	—
Part A: Maximum Observed Plasma Concentration (Cmax) of Rilzabrutinib Cycle 2 Day 1	—	396 nanogram per milliliter (ng/mL) Standard Deviation 257	—	451 nanogram per milliliter (ng/mL) Standard Deviation 408	—
Part A: Maximum Observed Plasma Concentration (Cmax) of Rilzabrutinib Cycle 3 Day 1	319 nanogram per milliliter (ng/mL) Standard Deviation 266	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 3, and 5 (each cycle 28 days)

Plasma samples were collected at specified timepoints to determine tmax of rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=9 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=43 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=7 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Time of Observed Maximum Plasma Concentration (Tmax) of Rilzabrutinib Cycle 1 Day 1	1.50 hours (h) Interval 1.0 to 1.53	1.50 hours (h) Interval 0.5 to 4.0	1.43 hours (h) Interval 0.5 to 2.0	—	—
Part A: Time of Observed Maximum Plasma Concentration (Tmax) of Rilzabrutinib Cycle 2 Day 1	—	1.05 hours (h) Interval 0.5 to 2.0	—	2.00 hours (h) Interval 1.0 to 3.03	—
Part A: Time of Observed Maximum Plasma Concentration (Tmax) of Rilzabrutinib Cycle 3 Day 1	1.50 hours (h) Interval 0.5 to 3.0	—	—	—	—
Part A: Time of Observed Maximum Plasma Concentration (Tmax) of Rilzabrutinib Cycle 5 Day 1	—	1.25 hours (h) Interval 1.0 to 1.5	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, 3, and 5 (each cycle 28 days)

Plasma samples were collected at specified timepoints to determine AUClast of rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=9 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=43 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=7 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Rilzabrutinib Cycle 1 Day 1	616 h*ng/mL Standard Deviation 334	642 h*ng/mL Standard Deviation 435	320 h*ng/mL Standard Deviation 217	—	—
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Rilzabrutinib Cycle 2 Day 1	—	1150 h*ng/mL Standard Deviation 1030	—	986 h*ng/mL Standard Deviation 646	—
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Rilzabrutinib Cycle 3 Day 1	788 h*ng/mL Standard Deviation 610	—	—	—	—
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Rilzabrutinib Cycle 5 Day 1	—	872 h*ng/mL Standard Deviation 412	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, and 3 (each cycle 28 days)

Plasma samples were collected at specified timepoints to determine AUCinf of rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=7 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=35 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=5 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rilzabrutinib Cycle 1 Day 1	653 h*ng/mL Standard Deviation 351	703 h*ng/mL Standard Deviation 455	331 h*ng/mL Standard Deviation 224	—	—
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rilzabrutinib Cycle 2 Day 1	—	827 h*ng/mL Standard Deviation NA SD cannot be calculated for a single participant.	—	787 h*ng/mL Standard Deviation 446	—
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rilzabrutinib Cycle 3 Day 1	818 h*ng/mL Standard Deviation 671	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, and 3 (each cycle 28 days)

Plasma samples were collected at specified timepoints to determine t1/2 of rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=7 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=37 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=6 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Elimination Half-Life (t1/2) of Rilzabrutinib Cycle 1 Day 1	1.30 hours Interval 1.15 to 1.95	1.32 hours Interval 0.78 to 3.24	1.36 hours Interval 1.09 to 1.5	—	—
Part A: Elimination Half-Life (t1/2) of Rilzabrutinib Cycle 2 Day 1	—	1.34 hours Interval 1.34 to 1.34	—	1.52 hours Interval 1.17 to 3.89	—
Part A: Elimination Half-Life (t1/2) of Rilzabrutinib Cycle 3 Day 1	1.60 hours Interval 1.18 to 1.88	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, and 3 (each cycle 28 days)

Plasma samples were collected at specified timepoints to determine Vz/F of rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=7 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=35 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=5 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Apparent Volume of Distribution of the Drug After Oral Administration (Vz/F) of Rilzabrutinib Cycle 1 Day 1	1180 Liters Standard Deviation 611	1720 Liters Standard Deviation 1460	1780 Liters Standard Deviation 1180	—	—
Part A: Apparent Volume of Distribution of the Drug After Oral Administration (Vz/F) of Rilzabrutinib Cycle 2 Day 1	—	934 Liters Standard Deviation NA SD cannot be calculated for a single participant.	—	2090 Liters Standard Deviation 2640	—
Part A: Apparent Volume of Distribution of the Drug After Oral Administration (Vz/F) of Rilzabrutinib Cycle 3 Day 1	1650 Liters Standard Deviation 1510	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 of Cycles 1, 2, and 3 (each cycle 28 days)

Plasma samples were collected at specified timepoints to determine CL/F of rilzabrutinib.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID n=7 Participants All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=35 Participants All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=9 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD n=5 Participants All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part A: Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Rilzabrutinib Cycle 1 Day 1	592 liters/hour Standard Deviation 320	854 liters/hour Standard Deviation 551	911 liters/hour Standard Deviation 569	—	—
Part A: Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Rilzabrutinib Cycle 2 Day 1	—	484 liters/hour Standard Deviation NA SD cannot be calculated for a single participant.	—	743 liters/hour Standard Deviation 593	—
Part A: Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Rilzabrutinib Cycle 3 Day 1	713 liters/hour Standard Deviation 621	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose and 2 hours post-dose on Days 1, 29, and 57

Population: PK population consisted of all enrolled participants from the safety population who had at least 1 post-baseline PK result.

Plasma samples were collected at specified timepoints for evaluation of rilzabrutinib pharmacokinetic (PK) concentrations.

Outcome measures

Outcome measures
Measure	Part A: Dose Level 300 mg BID All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part B: Rilzabrutinib 400 mg BID n=25 Participants Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.	Part A: Dose Level 400 mg QD All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.
Part B: Plasma Concentration of Rilzabrutinib Day 1: pre-dose	—	—	NA ng/mL Standard Deviation NA Mean and SD were not calculated as the values were below the lower limit of quantification (LLOQ=0.100 ng/mL).	—	—
Part B: Plasma Concentration of Rilzabrutinib Day 1: 2 hours post-dose	—	—	154.09 ng/mL Standard Deviation 131.79	—	—
Part B: Plasma Concentration of Rilzabrutinib Day 29: pre-dose	—	—	5.07 ng/mL Standard Deviation 8.61	—	—
Part B: Plasma Concentration of Rilzabrutinib Day 29: 2 hours post-dose	—	—	228.67 ng/mL Standard Deviation 173.68	—	—
Part B: Plasma Concentration of Rilzabrutinib Day 57: pre-dose	—	—	26.42 ng/mL Standard Deviation 90.43	—	—
Part B: Plasma Concentration of Rilzabrutinib Day 57: 2 hours post-dose	—	—	331.81 ng/mL Standard Deviation 151.07	—	—

Adverse Events

Part A: Dose Level 200 mg QD

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A: Dose Level 400 mg QD

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: Dose Level 300 mg BID

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Part A: Dose Level 400 mg BID

Serious events: 9 serious events

Other events: 43 other events

Deaths: 1 deaths

Part A: Overall

Serious events: 11 serious events

Other events: 48 other events

Deaths: 1 deaths

Part B: 400 mg BID

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Dose Level 200 mg QD n=9 participants at risk All participants who received rilzabrutinib 200 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg QD n=8 participants at risk All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 300 mg BID n=12 participants at risk All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=52 participants at risk All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=60 participants at risk All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.	Part B: 400 mg BID n=26 participants at risk Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.
Infections and infestations Covid-19 Pneumonia	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Infections and infestations Pneumonia	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Infections and infestations Subcutaneous Abscess	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Blood and lymphatic system disorders Evans Syndrome	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Blood and lymphatic system disorders Immune Thrombocytopenia	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 2/52 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.3% 2/60 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Nervous system disorders Syncope	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Eye disorders Iridocyclitis	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Injury, poisoning and procedural complications Contusion	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Injury, poisoning and procedural complications Traumatic Haematoma	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.

Other adverse events

Other adverse events
Measure	Part A: Dose Level 200 mg QD n=9 participants at risk All participants who received rilzabrutinib 200 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg QD n=8 participants at risk All participants who received rilzabrutinib 400 mg orally QD over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 300 mg BID n=12 participants at risk All participants who received rilzabrutinib 300 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Dose Level 400 mg BID n=52 participants at risk All participants who received rilzabrutinib 400 mg orally BID over 24 weeks of treatment period, unless withdrawn or had a platelet response to current dose level.	Part A: Overall n=60 participants at risk All participants who received rilzabrutinib (200 mg QD or 400 mg QD or 300 mg BID or 400 mg BID) at all dose levels over 24 weeks of treatment period, unless withdrawn or had a platelet response to dose level.	Part B: 400 mg BID n=26 participants at risk Participants received rilzabrutinib 400 mg orally BID from Day 1 up to 24 weeks of treatment period.
Infections and infestations Covid-19	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	23.1% 6/26 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Infections and infestations Nasopharyngitis	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	9.6% 5/52 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 5/60 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	15.4% 4/26 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 4/52 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	6.7% 4/60 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Blood and lymphatic system disorders Haemorrhagic Diathesis	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Psychiatric disorders Abnormal Dreams	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Psychiatric disorders Anxiety	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	13.5% 7/52 • Number of events 9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	11.7% 7/60 • Number of events 9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	34.6% 9/26 • Number of events 13 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Eye disorders Conjunctival Haemorrhage	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	9.6% 5/52 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 5/60 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Eye disorders Iridocyclitis	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Ear and labyrinth disorders Ear Pruritus	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Cardiac disorders Palpitations	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Vascular disorders Haematoma	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Vascular disorders Hypertension	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	15.4% 4/26 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 2/52 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.3% 2/60 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Abdominal Distension	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	16.7% 2/12 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	11.5% 6/52 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	10.0% 6/60 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Abdominal Pain	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Abdominal Pain Upper	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	19.2% 5/26 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Aphthous Ulcer	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Diarrhoea	22.2% 2/9 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	25.0% 2/8 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	25.0% 3/12 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	42.3% 22/52 • Number of events 30 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	38.3% 23/60 • Number of events 31 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	46.2% 12/26 • Number of events 16 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	16.7% 2/12 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	6.7% 4/60 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	19.2% 5/26 • Number of events 6 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	15.4% 4/26 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Gingival Bleeding	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Inguinal Hernia	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Loose Tooth	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Nausea	22.2% 2/9 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	25.0% 2/8 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	33.3% 4/12 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	36.5% 19/52 • Number of events 25 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	35.0% 21/60 • Number of events 27 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	26.9% 7/26 • Number of events 11 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Toothache	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	9.6% 5/52 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 5/60 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Skin and subcutaneous tissue disorders Petechiae	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 4/52 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	6.7% 4/60 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Skin and subcutaneous tissue disorders Purpura	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 2/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.3% 2/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 4/52 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	6.7% 4/60 • Number of events 5 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Skin and subcutaneous tissue disorders Scab	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	11.5% 6/52 • Number of events 9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	10.0% 6/60 • Number of events 9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Musculoskeletal and connective tissue disorders Back Pain	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	17.3% 9/52 • Number of events 11 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	16.7% 10/60 • Number of events 12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 1/26 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Musculoskeletal and connective tissue disorders Joint Swelling	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Renal and urinary disorders Micturition Urgency	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
General disorders Fatigue	22.2% 2/9 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	25.0% 2/8 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	16.7% 2/12 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	23.1% 12/52 • Number of events 14 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	21.7% 13/60 • Number of events 15 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	11.5% 3/26 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
General disorders Influenza Like Illness	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/52 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/60 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
General disorders Malaise	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
General disorders Peripheral Swelling	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.8% 3/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
General disorders Vessel Puncture Site Bruise	11.1% 1/9 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
General disorders Vessel Puncture Site Discharge	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Investigations Alanine Aminotransferase Increased	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Investigations Aspartate Aminotransferase Increased	0.00% 0/9 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/8 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/12 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	7.7% 2/26 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Injury, poisoning and procedural complications Arthropod Bite	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	16.7% 2/12 • Number of events 2 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	3.8% 2/52 • Number of events 3 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	5.0% 3/60 • Number of events 4 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Injury, poisoning and procedural complications Contusion	33.3% 3/9 • Number of events 7 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	37.5% 3/8 • Number of events 7 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	25.0% 3/12 • Number of events 7 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	19.2% 10/52 • Number of events 18 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	20.0% 12/60 • Number of events 20 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	19.2% 5/26 • Number of events 10 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Injury, poisoning and procedural complications Humerus Fracture	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.
Injury, poisoning and procedural complications Limb Injury	11.1% 1/9 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	12.5% 1/8 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	8.3% 1/12 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.9% 1/52 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	1.7% 1/60 • Number of events 1 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.	0.00% 0/26 • Adverse events data was collected from first dose of rilzabrutinib (Day 1) up to last dose + 1, approximately up to 294 days (Part A) and up to 170 days (Part B). All-cause mortality (death) was assessed from the signing of the ICF up to primary completion date (31 January 2023) approximately 253 weeks. Analysis was performed on safety population. As pre-specified (SAP), AEs were presented by dose level and overall . A participants could be classified into multiple dose levels.

Additional Information

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