Trial Outcomes & Findings for Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) (NCT NCT02910583)

NCT ID: NCT02910583

Last Updated: 2024-12-20

Results Overview

DFS is defined as time from randomization date to MRD-positive relapse, or disease progression per investigator assessment (per 2008 International Workshop for Chronic Lymphocytic Leukemia \[IWCLL\] criteria \[Halleck et al\]) or death from any cause, whichever occurred first. 1-year DFS estimated using Kaplan-Meier method at 12 months landmark time.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 323 participants
• Primary outcome timeframe: 1 year after randomization
• Results posted on: 2024-12-20

Participant Flow

This study was conducted at 39 centers in the United States (US), Australia, New Zealand, Spain, and Italy.

Upon completion of a pre-randomization phase, participants in the MRD Cohort with confirmed undetectable minimal residual disease (uMRD) were randomized to blinded ibrutinib or placebo. Participants in the MRD Cohort with uMRD not confirmed were randomized to open-label ibrutinib or open-label ibrutinib + venetoclax.

Participant milestones

Measure	Fixed Duration (FD) Cohort: All Treated Participants received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity, whichever was earlier. Participants with confirmed progression per 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria after completion of the fixed duration regimen could be retreated with continuous single agent ibrutinib until disease progression or unacceptable toxicity, whichever was earlier, because it is an established standard of care for treatment of relapsed chronic lymphocytic leukemia (CLL). For participants who experienced durable efficacy after ibrutinib plus venetoclax (ie, time to progression after fixed duration regimen is completed of \>2 years), the ibrutinib plus venetoclax fixed duration treatment regimen may have been repeated based on Investigator's clinical discretion and Medical Monitor's approval. Retreatment was for 15 cycles, until disease progression (PD) or unacceptable toxicity, whichever was earlier.	Minimal Residual Disease (MRD) Cohort: All Treated Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants who completed the planned pre-randomization treatment were eligible to be randomized according to their confirmed undetectable minimal residual disease (uMRD) status: Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. The venetoclax could be administered cumulative from pre-randomization to randomization phase at the dose of 400 mg/day for up to approximately 2 years, or earlier PD or unacceptable toxicity.
Overall Study STARTED	159	164
Overall Study MRD Cohort/ Not Randomized	0	15
Overall Study MRD Cohort/ Confirmed uMRD: Randomized to Ibrutinib (Blinded)	0	43
Overall Study MRD Cohort/ Confirmed uMRD: Randomized Placebo (Blinded)	0	43
Overall Study MRD Cohort/uMRD Not Confirmed: Randomized to Ibrutinib (Open-Label)	0	31
Overall Study MRD Cohort/uMRD Not Confirmed: Randomized Ibrutinib + Venetoclax (Open-Label)	0	32
Overall Study COMPLETED	133	150
Overall Study NOT COMPLETED	26	14

Reasons for withdrawal

Measure	Fixed Duration (FD) Cohort: All Treated Participants received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity, whichever was earlier. Participants with confirmed progression per 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria after completion of the fixed duration regimen could be retreated with continuous single agent ibrutinib until disease progression or unacceptable toxicity, whichever was earlier, because it is an established standard of care for treatment of relapsed chronic lymphocytic leukemia (CLL). For participants who experienced durable efficacy after ibrutinib plus venetoclax (ie, time to progression after fixed duration regimen is completed of \>2 years), the ibrutinib plus venetoclax fixed duration treatment regimen may have been repeated based on Investigator's clinical discretion and Medical Monitor's approval. Retreatment was for 15 cycles, until disease progression (PD) or unacceptable toxicity, whichever was earlier.	Minimal Residual Disease (MRD) Cohort: All Treated Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants who completed the planned pre-randomization treatment were eligible to be randomized according to their confirmed undetectable minimal residual disease (uMRD) status: Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. The venetoclax could be administered cumulative from pre-randomization to randomization phase at the dose of 400 mg/day for up to approximately 2 years, or earlier PD or unacceptable toxicity.
Overall Study Death	7	3
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	12	8
Overall Study Other, Not Specified	6	3

Baseline Characteristics

Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)

Baseline characteristics by cohort

Measure	FD Cohort: All Treated n=159 Participants Participants received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until disease progression or unacceptable toxicity, whichever was earlier. Participants with confirmed progression per 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria after completion of the fixed duration regimen could be retreated with continuous single agent ibrutinib until disease progression or unacceptable toxicity, whichever was earlier, because it is an established standard of care for treatment of relapsed chronic lymphocytic leukemia (CLL). For participants who experienced durable efficacy after ibrutinib plus venetoclax (ie, time to progression after fixed duration regimen is completed of \>2 years), the ibrutinib plus venetoclax fixed duration treatment regimen may have been repeated based on Investigator's clinical discretion and Medical Monitor's approval. Retreatment was for 15 cycles, until disease progression (PD) or unacceptable toxicity.	MRD Cohort: All Treated n=164 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants who completed the planned pre-randomization treatment were eligible to be randomized according to their confirmed undetectable minimal residual disease (uMRD) status: Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. The venetoclax could be administered cumulative from pre-randomization to randomization phase at the dose of 400 mg/day for up to approximately 2 years, or earlier PD or unacceptable toxicity.	Total n=323 Participants Total of all reporting groups
Age, Customized < 65 years	114 Participants n=5 Participants	123 Participants n=7 Participants	237 Participants n=5 Participants
Age, Customized >= 65 years	45 Participants n=5 Participants	41 Participants n=7 Participants	86 Participants n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	61 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	103 Participants n=7 Participants	209 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=5 Participants	150 Participants n=7 Participants	299 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	147 Participants n=5 Participants	147 Participants n=7 Participants	294 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year after randomization

Population: Confirmed uMRD Randomized Population: all participants who achieved confirmed MRD-negative clinical response at the end of the pre-randomization phase, randomized to either blinded placebo arm or blinded ibrutinib arm.

DFS is defined as time from randomization date to MRD-positive relapse, or disease progression per investigator assessment (per 2008 International Workshop for Chronic Lymphocytic Leukemia [IWCLL] criteria [Halleck et al]) or death from any cause, whichever occurred first. 1-year DFS estimated using Kaplan-Meier method at 12 months landmark time.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: 1-Year Disease-Free Survival (DFS) Rate in Confirmed uMRD Randomized Participants	100.0 percentage of participants Interval 100.0 to 100.0	95.3 percentage of participants Interval 82.7 to 98.8	—	—	—

PRIMARY outcome

Timeframe: From the first dose of ibrutinib to the first confirmed PD, for a median follow-up of 69.0 months.

Population: Per protocol, the primary analysis of the primary endpoint for the FD cohort was based on the FD Cohort, Non-Del 17p Population only.

CR/CRi rate is defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi) per 2008 IWCLL criteria (halleck et al.) on or prior to initiation of subsequent antineoplastic therapy or, if applicable, reintroduction of study treatment, whichever occurred earlier.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=136 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=159 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: Complete Response Rate (CRR; Complete Response/Complete Response With Incomplete Blood Count Recovery [CR/CRi]) Rate	58.1 percentage of participants Interval 49.8 to 66.4	57.2 percentage of participants Interval 49.5 to 64.9	—	—	—

SECONDARY outcome

Timeframe: From the first dose of ibrutinib to the first confirmed PD, for an overall median follow-up of 67.0 months. (Median follow up duration for the individual MRD Cohort treatment arms listed above.)

Population: MRD Cohort - All Treated Population

CR/CRi rate is defined as the percentage of participants achieving a best overall response of CR or CRi per 2008 IWCLL criteria (Halleck et al.) on or prior to initiation of subsequent antineoplastic therapy or, if applicable, reintroduction of study treatment, whichever occurred earlier.

Median follow up duration for the individual MRD Cohort treatment arms: Confirmed uMRD Ibrutinib arm 69.1 months; Confirmed uMRD Placebo arm 67.4 months; uMRD Not Confirmed Ibrutinib arm 47.9 months; uMRD Not Confirmed Ibrutinib + Venetoclax arm 47.9 months.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=164 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib n=31 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax n=32 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: CRR (CR/CRi Rate)	66.5 percentage of participants Interval 59.2 to 73.7	79.1 percentage of participants Interval 66.9 to 91.2	65.1 percentage of participants Interval 50.9 to 79.4	77.4 percentage of participants Interval 62.7 to 92.1	56.3 percentage of participants Interval 39.1 to 73.4

SECONDARY outcome

Timeframe: From the first dose of ibrutinib to the first confirmed PD, for an overall median follow-up of 67.0 months. (Median follow up duration for the individual MRD Cohort treatment arms listed above.)

Population: MRD Cohort - All Treated Population

ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), CR with incomplete blood count recovery (CRi), nodular partial response (nPR), partial response (PR), or PR with lymphocytosis (PRL) evaluated in accordance with the 2008 IWCLL criteria (Halleck et al). Participants who did not have any postbaseline response assessment were considered as non-responders. This table is based on response assessments performed on or prior to initiation of subsequent antineoplastic therapy or, if applicable, reintroduction of study treatment, whichever occurs earlier. Kaplan-Meier estimate.

Median follow up duration for the individual MRD Cohort treatment arms: Confirmed uMRD Ibrutinib arm 69.1 months; Confirmed uMRD Placebo arm 67.4 months; uMRD Not Confirmed Ibrutinib arm 47.9 months; uMRD Not Confirmed Ibrutinib + Venetoclax arm 47.9 months.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=164 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib n=31 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax n=32 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: Overall Response Rate (ORR)	97.0 percentage of participants Interval 94.3 to 99.6	100.0 percentage of participants Interval 100.0 to 100.0	100.0 percentage of participants Interval 100.0 to 100.0	100.0 percentage of participants Interval 100.0 to 100.0	100.0 percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: From initial documentation of a response until PD or death from any cause, whichever occurs first, for an overall median follow-up of 67.0 months. (Median follow up duration for the individual MRD Cohort treatment arms listed above.)

Population: MRD Cohort: Participants who achieved PR or better

Duration of response was calculated for participants achieving a response (CR, CRi, nPR, PR) based on 2008 IWCLL response criteria (Halleck et al.) and defined as the interval between the date of initial documentation of a response including PR with lymphocytosis, until disease progression (PD) or death from any cause, whichever occurred first. As the median DOR was not reached as of 67.0 months study follow-up, the Kaplan-Meier estimate of DOR at 42 months landmark time was presented.

Median follow up duration for the individual MRD Cohort treatment arms: Confirmed uMRD Ibrutinib arm 69.1 months; Confirmed uMRD Placebo arm 67.4 months; uMRD Not Confirmed Ibrutinib arm 47.9 months; uMRD Not Confirmed Ibrutinib + Venetoclax arm 47.9 months.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=159 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib n=31 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax n=32 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: Duration of Response (DOR) at 42 Months Landmark Time	93.5 percentage of participants Interval 88.2 to 96.4	97.6 percentage of participants Interval 84.3 to 99.7	93.0 percentage of participants Interval 79.7 to 97.7	96.7 percentage of participants Interval 78.6 to 99.5	93.2 percentage of participants Interval 75.5 to 98.3

SECONDARY outcome

Timeframe: From randomization date until before any subsequent antineoplastic therapy, for an overall median follow-up of 67.0 months. (Median follow up duration for the individual MRD Cohort treatment arms listed above.)

Population: MRD All Treated Population; participants with an assessment.

MRD negativity rate is defined as the percentage of participants achieving MRD negativity, which is defined as <1 CLL cell per 10,000 leukocytes (<1 x 10^-4) as assessed by flow cytometry of a peripheral blood (PB) or bone marrow (BM) aspirate sample per central laboratory on or prior to initiation of subsequent antineoplastic therapy or, if applicable, reintroduction of study treatment, whichever occurs earlier.

Median follow up duration for the individual MRD Cohort treatment arms: Confirmed uMRD Ibrutinib arm 69.1 months; Confirmed uMRD Placebo arm 67.4 months; uMRD Not Confirmed Ibrutinib arm 47.9 months; uMRD Not Confirmed Ibrutinib + Venetoclax arm 47.9 months.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=164 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=63 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=31 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib n=32 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: MRD-Negativity Rate PB or BM	81.7 percentage of participants Interval 75.8 to 87.6	65.1 percentage of participants Interval 53.3 to 76.9	51.6 percentage of participants Interval 34.0 to 69.2	78.1 percentage of participants Interval 63.8 to 92.4	—
MRD Cohort: MRD-Negativity Rate BM	77.4 percentage of participants Interval 71.0 to 83.8	55.6 percentage of participants Interval 43.3 to 67.8	41.9 percentage of participants Interval 24.6 to 59.3	68.8 percentage of participants Interval 52.7 to 84.8	—
MRD Cohort: MRD-Negativity Rate PB	79.9 percentage of participants Interval 73.7 to 86.0	60.3 percentage of participants Interval 48.2 to 72.4	48.4 percentage of participants Interval 30.8 to 66.0	71.9 percentage of participants Interval 56.3 to 87.5	—

SECONDARY outcome

Timeframe: Baseline, and last post-baseline value on or prior to venetoclax first dose date (cycle 4 day 1) or, for participants who never received venetoclax, the post-baseline value closest to cycle 4 day 1 (i.e. 84 days after the first dose date of ibrutinib).

Population: MRD Cohort: All Treated Population with baseline TLS high risk

TLS risk reduction was summarized by the percentage of participants with TLS risk reduced from high at baseline to medium or low after ibrutinib lead-in. A reduction in TLS risk from high risk to medium or low risk is clinically meaningful because there is a reduction in the extent of TLS monitoring and risk of hospitalization. TLS risk category is defined as the tumor burden category, where: Low=All lymph nodes (LN) < 5 cm AND absolute lymphocyte count (ALC) < 25 x 10^9/L; Medium=Any LN 5 cm to < 10 cm OR ALC ≥ 25 x 10^9/L; High=Any LN ≥ 10 cm OR ALC ≥ 25 x10^9/L AND any LN ≥ 5 cm.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=40 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: Tumor Lysis Syndrome (TLS) Risk Reduction Rate With 3-Cycle Ibrutinib Lead-In (Percentage of Participants No Longer High Risk After 3-cycle Lead-in)	90.0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of ibrutinib to the first confirmed PD or death, for an overall median follow-up of 67.0 months. (Median follow up duration for the individual MRD Cohort treatment arms listed above.)

Population: MRD Cohort - All Treated Population

PFS was defined as time from the first dose date of study treatment until disease progression (PD) or death from any cause, whichever occurs first. Assessment of PD was conducted in accordance with the 2008 IWCLL criteria (Halleck et al). As the median PFS was not reached as of the overall median 67.0 months study follow-up, the Kaplan-Meier estimate of PFS rate at 48 months landmark time was presented.

Median follow up duration for the individual MRD Cohort treatment arms: Confirmed uMRD Ibrutinib arm 69.1 months; Confirmed uMRD Placebo arm 67.4 months; uMRD Not Confirmed Ibrutinib arm 47.9 months; uMRD Not Confirmed Ibrutinib + Venetoclax arm 47.9 months.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=164 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib n=31 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax n=32 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: Kaplan-Meier Estimate of Progression Free Survival (PFS) Rate at 48 Months Landmark Time	90.9 percentage of participants Interval 85.1 to 94.5	97.6 percentage of participants Interval 84.3 to 99.7	88.2 percentage of participants Interval 73.9 to 94.9	93.3 percentage of participants Interval 75.9 to 98.3	93.2 percentage of participants Interval 75.5 to 98.3

SECONDARY outcome

Timeframe: From the first dose of ibrutinib to time of death, for an overall median follow-up of 67.0 months. (Median follow up duration for the individual MRD Cohort treatment arms listed above.)

Population: MRD Cohort - All Treated Population

OS is defined as the time from the first dose date of study treatment until date of death due to any cause. As the median OS was not reached as of the overall median 67.0 months study follow-up, the Kaplan-Meier estimate of OS rate at 48 months landmark time was presented.

Median follow up duration for the individual MRD Cohort treatment arms: Confirmed uMRD: Randomized to Ibrutinib=69.1 months; Confirmed uMRD: Randomized to Placebo=67.4 months; uMRD Not Confirmed: Randomized to Open-Label Ibrutinib=47.9 months; uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax=47.9 months.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=164 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib n=31 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax n=32 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: Kaplan-Meier Estimate of Overall Survival (OS) Rate at 48 Months Landmark Time	98.0 percentage of participants Interval 94.0 to 99.4	97.6 percentage of participants Interval 84.3 to 99.7	100.0 percentage of participants Interval 100.0 to 100.0	96.7 percentage of participants Interval 78.6 to 99.5	100.0 percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: From first dose until 30 days following last dose of study drug. Overall median treatment duration for the MRD cohort was 45.1 months.

Population: All Treated Population

An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires unplanned in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity of events were graded according to the Common Terminology Criteria for Adverse Events version 4.03: mild=grade1, moderate=grade 2, severe=grade 3, life-threatening=grade 4, death=grade 5. Causal relation of study drug and event was assessed as not related, unlikely, possibly or probably related to the study drug.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=164 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=43 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib n=31 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax n=32 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Fatal TEAE	1.2 percentage of participants	2.3 percentage of participants	0 percentage of participants	3.2 percentage of participants	0 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Major Hemorrhage TEAE	2.4 percentage of participants	2.3 percentage of participants	0 percentage of participants	3.2 percentage of participants	6.3 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Grade >= 3 Major Hemorrhage TEAE	1.8 percentage of participants	2.3 percentage of participants	0 percentage of participants	3.2 percentage of participants	3.1 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Major Hemorrhage SAE	2.4 percentage of participants	2.3 percentage of participants	0 percentage of participants	3.2 percentage of participants	6.3 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation: Ibr Only	10.4 percentage of participants	14.0 percentage of participants	0 percentage of participants	9.7 percentage of participants	3.1 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Grade >=3 TEAE	75.6 percentage of participants	83.7 percentage of participants	72.1 percentage of participants	71.0 percentage of participants	78.1 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Ibrutinib (Ibr)-Related TEAE	95.7 percentage of participants	97.7 percentage of participants	93.0 percentage of participants	96.8 percentage of participants	93.8 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Grade >=3 Ibrutinib-Related TEAE	57.9 percentage of participants	55.8 percentage of participants	51.2 percentage of participants	61.3 percentage of participants	62.5 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Venetoclax (Ven)-Related TEAE	81.1 percentage of participants	88.4 percentage of participants	76.7 percentage of participants	80.6 percentage of participants	96.9 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Grade >=3 Venetoclax-Related TEAE	44.5 percentage of participants	51.2 percentage of participants	34.9 percentage of participants	45.2 percentage of participants	56.3 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation	15.9 percentage of participants	16.3 percentage of participants	0 percentage of participants	9.7 percentage of participants	12.5 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation: Ven Only	1.2 percentage of participants	2.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation: Both Ibr and Ven	4.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	9.4 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Ibr-related SAE	17.1 percentage of participants	14.0 percentage of participants	11.6 percentage of participants	22.6 percentage of participants	18.8 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Dose Reduction	26.2 percentage of participants	23.3 percentage of participants	25.6 percentage of participants	25.8 percentage of participants	34.4 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Ibr Only Dose Reduction	16.5 percentage of participants	16.3 percentage of participants	11.6 percentage of participants	19.4 percentage of participants	25.0 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Ven Only Dose Reduction	4.9 percentage of participants	2.3 percentage of participants	11.6 percentage of participants	0 percentage of participants	3.1 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any TEAE Leading to Both Ibr and Ven Dose Reduction	4.9 percentage of participants	4.7 percentage of participants	2.3 percentage of participants	6.5 percentage of participants	6.3 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any SAE	34.1 percentage of participants	34.9 percentage of participants	32.6 percentage of participants	41.9 percentage of participants	37.5 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Grade >= 3 SAE	28.7 percentage of participants	32.6 percentage of participants	27.9 percentage of participants	32.3 percentage of participants	28.1 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any SAE Related to Ibr or Ven	20.1 percentage of participants	18.6 percentage of participants	14.0 percentage of participants	25.8 percentage of participants	21.9 percentage of participants
MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs Any Ven-related SAE	6.7 percentage of participants	4.7 percentage of participants	7.0 percentage of participants	12.9 percentage of participants	6.3 percentage of participants

SECONDARY outcome

Timeframe: From the first dose of ibrutinib to the first confirmed PD, for a median follow-up of 69.0 months.

Population: FD Cohort: All Treated Population

ORR is defined as the percentage of participants who achieve a best overall response CR, CRi, nPR, PR, or PRL as evaluated by investigator using 2008 IWCLL criteria (Halleck et al.). Participants who did not have any postbaseline response assessment were considered as non-responders. This table is based on response assessments performed on or prior to initiation of subsequent antineoplastic therapy or, if applicable, reintroduction of study treatment, whichever occurs earlier. Kaplan-Meier estimate.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=136 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=159 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: ORR	95.6 percentage of participants Interval 92.1 to 99.0	96.2 percentage of participants Interval 93.3 to 99.2	—	—	—

SECONDARY outcome

Timeframe: From initial documentation of a response until PD or death from any cause, whichever occurs first, for a median follow-up of 69.0 months.

Population: FD Cohort: Participants who achieved PR or better.

Duration of response was calculated for participants achieving a response (CR, CRi, nPR, PR) based on 2008 IWCLL response criteria (Halleck et al.) and defined as the interval between the date of initial documentation of a response including PR with lymphocytosis, until disease progression (PD) or death from any cause, whichever occurred first. As the median DOR was not reached as of the median 27.9 months study follow-up, the Kaplan-Meier estimate of DOR at 60 months landmark time was presented.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=130 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=153 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: DOR at 60 Months Landmark Time	63.6 percentage of participants Interval 54.4 to 71.4	60.5 percentage of participants Interval 52.0 to 68.0	—	—	—

SECONDARY outcome

Timeframe: From randomization date until before any subsequent antineoplastic therapy, for a median follow-up of 69.0 months.

Population: FD Cohort - All Treated Population

MRD negativity rate is defined as the percentage of participants achieving MRD negativity, which is defined as <1 CLL cell per 10,000 leukocytes (<1 x 10^-4) as assessed by flow cytometry of a peripheral blood (PB) or bone marrow (BM) aspirate sample per central laboratory on or prior to initiation of subsequent antineoplastic therapy or, if applicable, reintroduction of study treatment, whichever occurs earlier.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=136 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=159 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: MRD Negativity Rate BM or PB	78.7 percentage of participants Interval 71.8 to 85.6	78.6 percentage of participants Interval 72.2 to 85.0	—	—	—
FD Cohort: MRD Negativity Rate BM	61.8 percentage of participants Interval 53.6 to 69.9	59.7 percentage of participants Interval 52.1 to 67.4	—	—	—
FD Cohort: MRD Negativity Rate PB	76.5 percentage of participants Interval 69.3 to 83.6	76.7 percentage of participants Interval 70.2 to 83.3	—	—	—

SECONDARY outcome

Timeframe: From the first dose of ibrutinib to the first confirmed PD or death, for an median follow-up of 69.0 months.

Population: FD Cohort - All Treated Population

PFS was defined as time from the first dose date of study treatment until disease progression (PD) or death from any cause, whichever occurs first. Assessment of PD was conducted in accordance with the 2008 IWCLL criteria (Halleck et al). As the median PFS was not reached as of the median 69.0 months study follow-up, the Kaplan-Meier estimate of PFS rate at 66 months landmark time was presented.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=136 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=159 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: Kaplan-Meier Estimate of PFS Rate at 66 Months Landmark Time	63.2 percentage of participants Interval 54.1 to 71.0	60.2 percentage of participants Interval 51.7 to 67.7	—	—	—

SECONDARY outcome

Timeframe: From the first dose of ibrutinib to time of death, for a median follow-up of 69.0 months.

Population: FD Cohort - All Treated Population

OS is defined as the time from the first dose date of study treatment until date of death due to any cause. As the median OS was not reached as of the median 69.0 months study follow-up, the Kaplan-Meier estimate of OS rate at 66 months landmark time was presented.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=136 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) n=159 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: Kaplan-Meier Estimate of OS Rate at 66 Months Landmark Time	96.9 percentage of participants Interval 92.1 to 98.8	96.1 percentage of participants Interval 91.4 to 98.2	—	—	—

SECONDARY outcome

Timeframe: Baseline, and last post-baseline value on or prior to venetoclax first dose date (cycle 4 day 1) or, for participants who never received venetoclax, the post-baseline value closest to cycle 4 day 1 (i.e. 84 days after the first dose date of ibrutinib).

Population: FD Cohort: All Treated Population with baseline TLS high risk

TLS risk reduction was summarized by the percentage of participants with TLS risk reduced from high at baseline to medium or low after ibrutinib lead-in. A reduction in TLS risk from high risk to medium or low risk is clinically meaningful because there is a reduction in the extent of TLS monitoring and risk of hospitalization. TLS risk category is defined as the tumor burden category, where: Low=All lymph nodes (LN) < 5 cm AND absolute lymphocyte count (ALC) < 25 x 10^9/L; Medium=Any LN 5 cm to < 10 cm OR ALC ≥ 25 x 10^9/L; High=Any LN ≥ 10 cm OR ALC ≥ 25 x10^9/L AND any LN ≥ 5 cm.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=34 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: TLS Risk Reduction Rate With 3-Cycle Ibrutinib Lead-In (Percentage of Participants No Longer High Risk After 3-cycle Lead-in)	94.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: From first dose until 30 days following last dose of study drug. Overall median treatment duration for the FD cohort was 13.8 months.

Population: FD Cohort: All Treated Population

An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires unplanned in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity of events were graded according to the Common Terminology Criteria for Adverse Events version 4.03: mild=grade1, moderate=grade 2, severe=grade 3, life-threatening=grade 4, death=grade 5. Causal relation of study drug and event was assessed as not related, unlikely, possibly or probably related to the study drug.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=159 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE	99.4 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Grade >=3 TEAE	62.3 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Ibrutinib (Ibr)-Related TEAE	92.5 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Grade >=3 Ibrutinib-Related TEAE	44.7 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Venetoclax (Ven)-Related TEAE	84.3 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Grade >=3 Venetoclax-Related TEAE	45.3 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation	5.0 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation: Ibr Only	3.1 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation: Ven Only	0 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Discontinuation: Both Ibr and Ven	1.9 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Ibr or Ven Dose Reduction	20.8 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Ibr Only Dose Reduction	5.7 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Ven Only Dose Reduction	11.3 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any TEAE Leading to Both Ibr and Ven Dose Reduction	3.8 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any SAE	23.3 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Grade >= 3 SAE	20.1 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any SAE Related to Ibr or Ven	13.8 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Ibr-related SAE	11.9 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Any Ven-related SAE	8.8 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Fatal TEAE	0.6 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Major Hemorrhage TEAE	1.9 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Grade >= 3 Major Hemorrhage TEAE	1.3 percentage of participants	—	—	—	—
FD Cohort: Percentage of Participants With TEAEs, Treatment-Emergent SAEs, and Discontinuations Due to TEAEs Major Hemorrhage SAE	1.3 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=130 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: Pharmacokinetics (PK) of Ibrutinib When Dosed in Combination With Venetoclax: Observed Maximum Concentration (Cmax)	88.5 ng/mL Geometric Coefficient of Variation 74.3	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for each PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=130 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Ibrutinib When Dosed in Combination With Venetoclax: Time to Cmax (Tmax); Time of Last Measurable Concentration (Tlast); Terminal Elimination Half-Life (t1/2,Term) tmax	2.00 hours Interval 0.97 to 7.0	—	—	—	—
MRD Cohort: PK of Ibrutinib When Dosed in Combination With Venetoclax: Time to Cmax (Tmax); Time of Last Measurable Concentration (Tlast); Terminal Elimination Half-Life (t1/2,Term) tlast	24.0 hours Interval 5.75 to 24.0	—	—	—	—
MRD Cohort: PK of Ibrutinib When Dosed in Combination With Venetoclax: Time to Cmax (Tmax); Time of Last Measurable Concentration (Tlast); Terminal Elimination Half-Life (t1/2,Term) t1/2term	5.30 hours Interval 1.47 to 10.5	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for each PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=128 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Ibrutinib When Dosed in Combination With Venetoclax: Area Under the Plasma Concentration-Time Curve (AUC) Over the Last 24-hour Dosing Interval (AUC0-24h); AUC From Time Zero to the Time of Last Quantifiable Concentration (AUClast) AUC0-24h	504 ng*h/mL Geometric Coefficient of Variation 76.3	—	—	—	—
MRD Cohort: PK of Ibrutinib When Dosed in Combination With Venetoclax: Area Under the Plasma Concentration-Time Curve (AUC) Over the Last 24-hour Dosing Interval (AUC0-24h); AUC From Time Zero to the Time of Last Quantifiable Concentration (AUClast) AUClast	480 ng*h/mL Geometric Coefficient of Variation 78.5	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=91 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Ibrutinib When Dosed in Combination With Venetoclax: Terminal Elimination Rate Constant (λz)	0.132 1/h Geometric Coefficient of Variation 44.5	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=128 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Ibrutinib When Dosed in Combination With Venetoclax: Apparent Total Clearance at Steady-State (CLss/F)	833 L/h Geometric Coefficient of Variation 90.9	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=131 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Venetoclax When Dosed in Combination With Ibrutinib: Cmax	3034 ng/mL Geometric Coefficient of Variation 56.3	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=131 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Venetoclax When Dosed in Combination With Ibrutinib: Tmax	6.00 hours Interval 0.0 to 8.08	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=131 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Venetoclax When Dosed in Combination With Ibrutinib: AUC0-24h	48993 ng*h/mL Geometric Coefficient of Variation 66.2	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 6 Day 1: predose, at dose, 1 h (±15 min), 2 h (±15 min), 4 h (±15 min), 6 h (±15 min), 8 h (±15 min)

Population: MRD Cohort: All treated participants who were evaluable for PK analysis. Data were collected for the MRD cohort only, and without regard to uMRD confirmation status/randomization group, as pre-specified for this analysis.

Outcome measures

Measure	MRD Cohort/Confirmed uMRD: Randomized to Ibrutinib (Blinded) n=131 Participants Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, PD, or unacceptable toxicity, whichever was earlier. After MRD-positive relapse or disease progression (PD) by iwCLL criteria, subjects can reintroduce 400 mg venetoclax with a 5-week ramp up. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/Confirmed uMRD: Randomized to Placebo (Blinded) Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, PD or unacceptable toxicity, whichever was earlier. If MRD-positive relapse or PD is confirmed after restaging per iwCLL criteria, participants could first reintroduce oral daily ibrutinib with the option of subsequently reintroducing 400 mg venetoclax with a 5-week ramp up, if subsequent disease relapse per iwCLL criteria occurs after ibrutinib reintroduction. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative), or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.	MRD Cohort/uMRD Not Confirmed: Randomized to Open-Label Ibrutinib + Venetoclax Participants received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity, whichever was earlier. In case of confirmed PD after restaging per iwCLL criteria, participants could continue ibrutinib and reintroduce venetoclax treatment. If venetoclax was reintroduced, venetoclax treatment was to continue at the dose of 400 mg/day for up to approximately 2 years (cumulative) or earlier PD or unacceptable toxicity.
MRD Cohort: PK of Venetoclax When Dosed in Combination With Ibrutinib: CLss/F	8.16 L/h Geometric Coefficient of Variation 69.7	—	—	—	—

Adverse Events

FD Cohort: Pre-Dose

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

MRD Cohort: Pre-Dose

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

FD Cohort: All Participants

Serious events: 37 serious events

Other events: 156 other events

Deaths: 5 deaths

MRD Cohort: All Participants

Serious events: 63 serious events

Other events: 163 other events

Deaths: 3 deaths

MRD Cohort: Confirmed uMRD (IbrVen->Ibr)

Serious events: 15 serious events

Other events: 43 other events

Deaths: 1 deaths

MRD Cohort: Confirmed uMRD (IbrVen->Pbo)

Serious events: 14 serious events

Other events: 43 other events

Deaths: 0 deaths

MRD Cohort: uMRD Not Confirmed (IbrVen->Ibr)

Serious events: 13 serious events

Other events: 31 other events

Deaths: 1 deaths

MRD Cohort: uMRD Not Confirmed (IbrVen->IbrVen)

Serious events: 12 serious events

Other events: 32 other events

Deaths: 0 deaths

FD Cohort: Reintroduced Ibrutinib

Serious events: 6 serious events

Other events: 14 other events

Deaths: 2 deaths

FD Cohort: Reintroduced Ibr+Ven

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

MRD Cohort: Reintroduced Ibrutinib

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

MRD Cohort: Reintroduced Ven + Continued Ibr

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	FD Cohort: Pre-Dose n=159 participants at risk All reported AEs that started prior to the first dose date of any study treatment in the FD Cohort.	MRD Cohort: Pre-Dose n=164 participants at risk All reported AEs started prior to the first dose date of any study treatment in the MRD Cohort.	FD Cohort: All Participants n=159 participants at risk Participants in the FD Cohort received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: All Participants n=164 participants at risk Participants in the MRD Cohort received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: Confirmed uMRD (IbrVen->Ibr) n=43 participants at risk Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (prerandomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, clinical PD, or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: Confirmed uMRD (IbrVen->Pbo) n=43 participants at risk Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, clinical PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: uMRD Not Confirmed (IbrVen->Ibr) n=31 participants at risk Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: uMRD Not Confirmed (IbrVen->IbrVen) n=32 participants at risk Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	FD Cohort: Reintroduced Ibrutinib n=18 participants at risk All reported AEs in the FD Cohort that started after the first dose date of reintroduced treatment with ibrutinib.	FD Cohort: Reintroduced Ibr+Ven n=11 participants at risk All reported AEs in the FD Cohort that started after the first dose date of reintroduced treatment with ibrutinib + venetoclax.	MRD Cohort: Reintroduced Ibrutinib n=7 participants at risk All reported AEs in the MRD Cohort that started after the first dose date of reintroduced treatment with ibrutinib.	MRD Cohort: Reintroduced Ven + Continued Ibr n=2 participants at risk All reported AEs in the MRD Cohort that started after the first dose date of reintroduced treatment with venetoclax and continued ibrutinib.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations CAMPYLOBACTER INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations CELLULITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations CELLULITIS ORBITAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders HAEMOLYSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders ANGINA PECTORIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders BRADYCARDIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders CARDIAC ARREST	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders CARDIAC FAILURE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders CORONARY ARTERY STENOSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders DILATED CARDIOMYOPATHY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders PALPITATIONS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders PERICARDITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders VENTRICULAR TACHYARRHYTHMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Congenital, familial and genetic disorders MALFORMATION VENOUS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Ear and labyrinth disorders VERTIGO	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Ear and labyrinth disorders VERTIGO POSITIONAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders EYE HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders MACULAR OEDEMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders RETINAL HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders COLITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders DIARRHOEA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders NAUSEA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders OESOPHAGEAL SPASM	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders PANCREATITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders RETROPERITONEAL HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders VOMITING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders PYREXIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders SUDDEN CARDIAC DEATH	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders SUDDEN DEATH	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Hepatobiliary disorders BILE DUCT STONE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Hepatobiliary disorders CHOLANGITIS ACUTE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Hepatobiliary disorders HEPATITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Immune system disorders ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations ABDOMINAL ABSCESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations APPENDICEAL ABSCESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations APPENDICITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations ARTHRITIS INFECTIVE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations BRONCHITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations COVID-19	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations DIVERTICULITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations EMPYEMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations ENCEPHALITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations ESCHERICHIA BACTERAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations GASTROENTERITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations HERPES ZOSTER DISSEMINATED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations INFLUENZA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION BACTERIAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations LYMPHADENITIS BACTERIAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PHARYNGITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PILONIDAL DISEASE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PNEUMONIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PNEUMONIA LEGIONELLA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PYELONEPHRITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PYOMYOSITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations SALMONELLOSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations SKIN INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations VIRAL INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations WEST NILE VIRAL INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations BLOOD PRESSURE DECREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations INFLUENZA B VIRUS TEST POSITIVE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders SPINAL SYNOVIAL CYST	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL ADENOCARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INVASIVE BREAST CARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INVASIVE DUCTAL BREAST CARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MENINGIOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL ONCOCYTOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TRANSITIONAL CELL CARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders ALTERED STATE OF CONSCIOUSNESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders AMNESIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders CEREBRAL VENOUS SINUS THROMBOSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders EPILEPSY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders HEADACHE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders HEPATIC ENCEPHALOPATHY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders VESTIBULAR MIGRAINE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders ANXIETY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders SCHIZOPHRENIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Renal and urinary disorders RENAL COLIC	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Reproductive system and breast disorders HEAVY MENSTRUAL BLEEDING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Reproductive system and breast disorders PELVIC HAEMATOMA	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders DERMATITIS BULLOUS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Vascular disorders CIRCULATORY COLLAPSE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Vascular disorders HYPERTENSION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.

Other adverse events

Measure	FD Cohort: Pre-Dose n=159 participants at risk All reported AEs that started prior to the first dose date of any study treatment in the FD Cohort.	MRD Cohort: Pre-Dose n=164 participants at risk All reported AEs started prior to the first dose date of any study treatment in the MRD Cohort.	FD Cohort: All Participants n=159 participants at risk Participants in the FD Cohort received 420 mg of single agent ibrutinib for first 3 cycles followed by ibrutinib plus venetoclax combination treatment (ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule) for 12 cycles (a cycle is defined by 28 days) or until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: All Participants n=164 participants at risk Participants in the MRD Cohort received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive blinded ibrutinib 420 mg or placebo orally once daily on a continuous schedule until PD or unacceptable toxicity. Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg or open-label ibrutinib 420 mg plus venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: Confirmed uMRD (IbrVen->Ibr) n=43 participants at risk Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (prerandomization phase). Participants with confirmed uMRD were randomized to receive ibrutinib 420 mg orally once daily on a continuous schedule until MRD-positive relapse, clinical PD, or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: Confirmed uMRD (IbrVen->Pbo) n=43 participants at risk Participants in the MRD Cohort with confirmed uMRD received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with confirmed uMRD were randomized to receive placebo orally once daily on a continuous schedule until MRD-positive relapse, clinical PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: uMRD Not Confirmed (IbrVen->Ibr) n=31 participants at risk Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	MRD Cohort: uMRD Not Confirmed (IbrVen->IbrVen) n=32 participants at risk Participants in the MRD Cohort with uMRD not confirmed received 420 mg of single-agent ibrutinib for the first 3 cycles followed by ibrutinib plus venetoclax combination treatment for at least 12 cycles (a cycle is defined as 28 days) prior to randomization (pre-randomization phase). Participants with uMRD not confirmed were randomized to receive open-label ibrutinib 420 mg and venetoclax 400 mg orally once daily on a continuous schedule until PD or unacceptable toxicity. 1. For participants who did not receive any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment over the whole study course. 2. For participants who received any reintroduced treatment, includes all reported AEs started after the first dose date of the first-line treatment and prior to the first dose date of the reintroduced treatment.	FD Cohort: Reintroduced Ibrutinib n=18 participants at risk All reported AEs in the FD Cohort that started after the first dose date of reintroduced treatment with ibrutinib.	FD Cohort: Reintroduced Ibr+Ven n=11 participants at risk All reported AEs in the FD Cohort that started after the first dose date of reintroduced treatment with ibrutinib + venetoclax.	MRD Cohort: Reintroduced Ibrutinib n=7 participants at risk All reported AEs in the MRD Cohort that started after the first dose date of reintroduced treatment with ibrutinib.	MRD Cohort: Reintroduced Ven + Continued Ibr n=2 participants at risk All reported AEs in the MRD Cohort that started after the first dose date of reintroduced treatment with venetoclax and continued ibrutinib.
Infections and infestations CONJUNCTIVITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders DYSGEUSIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders ANAEMIA	0.63% 1/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.3% 10/159 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.5% 14/164 • Number of events 26 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.6% 5/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders INCREASED TENDENCY TO BRUISE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	22.0% 35/159 • Number of events 44 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.0% 41/164 • Number of events 62 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	27.9% 12/43 • Number of events 19 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	35.5% 11/31 • Number of events 19 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.0% 8/32 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders LYMPHOCYTOSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	40.9% 65/159 • Number of events 169 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	43.3% 71/164 • Number of events 246 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	55.8% 24/43 • Number of events 107 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	34.9% 15/43 • Number of events 36 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	38.7% 12/31 • Number of events 29 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	43.8% 14/32 • Number of events 54 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders SPONTANEOUS HAEMATOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	13.2% 21/159 • Number of events 38 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.1% 33/164 • Number of events 72 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 21 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	31.2% 10/32 • Number of events 23 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.9% 13/164 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders PALPITATIONS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 15/159 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.5% 27/164 • Number of events 39 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 11/43 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders SINUS BRADYCARDIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Cardiac disorders SINUS TACHYCARDIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Ear and labyrinth disorders DEAFNESS NEUROSENSORY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Ear and labyrinth disorders VERTIGO	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders CATARACT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders CONJUNCTIVAL HYPERAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders DRY EYE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders RETINAL DETACHMENT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders RETINAL TEAR	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders UVEITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders VISION BLURRED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.9% 13/164 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Eye disorders VITREOUS HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.1% 10/164 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.3% 10/159 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 15/164 • Number of events 21 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders ABDOMINAL PAIN	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.2% 13/159 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	17.1% 28/164 • Number of events 34 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	50.0% 1/2 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.8% 14/159 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.2% 25/164 • Number of events 34 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	22.6% 7/31 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.6% 5/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders APHTHOUS ULCER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.0% 8/159 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders COLITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders CONSTIPATION	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.7% 25/159 • Number of events 31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.7% 34/164 • Number of events 47 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 11/43 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	29.0% 9/31 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 2/11 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders DIARRHOEA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	62.3% 99/159 • Number of events 203 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	72.6% 119/164 • Number of events 435 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	79.1% 34/43 • Number of events 91 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	65.1% 28/43 • Number of events 72 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	74.2% 23/31 • Number of events 56 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	87.5% 28/32 • Number of events 201 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.7% 3/18 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	36.4% 4/11 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	28.6% 2/7 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	100.0% 2/2 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders DRY MOUTH	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 29/159 • Number of events 38 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.3% 30/164 • Number of events 40 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	22.6% 7/31 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	21.9% 7/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders FLATULENCE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders GASTRITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.1% 16/159 • Number of events 19 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.3% 30/164 • Number of events 36 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	19.4% 6/31 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	21.9% 7/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	50.0% 1/2 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders GINGIVAL BLEEDING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders GLOSSODYNIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders LIP BLISTER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.1% 24/159 • Number of events 30 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 19/164 • Number of events 31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	19.4% 6/31 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders NAUSEA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	42.8% 68/159 • Number of events 97 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	48.8% 80/164 • Number of events 136 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	48.8% 21/43 • Number of events 40 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	46.5% 20/43 • Number of events 29 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	64.5% 20/31 • Number of events 36 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	37.5% 12/32 • Number of events 22 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 2/11 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	50.0% 1/2 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders ORAL PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders PROCTALGIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders SALIVARY GLAND ENLARGEMENT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders STOMATITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	13.2% 21/159 • Number of events 33 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	17.1% 28/164 • Number of events 61 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	19.4% 6/31 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 20 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders TOOTHACHE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Gastrointestinal disorders VOMITING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.8% 33/159 • Number of events 48 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 42/164 • Number of events 73 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	30.2% 13/43 • Number of events 26 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	22.6% 7/31 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	34.4% 11/32 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	50.0% 1/2 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders ASTHENIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.7% 9/159 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.3% 12/164 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders CHEST DISCOMFORT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders CHEST PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders CHILLS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.5% 14/164 • Number of events 19 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders FATIGUE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	24.5% 39/159 • Number of events 51 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	34.1% 56/164 • Number of events 102 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	32.6% 14/43 • Number of events 25 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	48.8% 21/43 • Number of events 37 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	32.3% 10/31 • Number of events 22 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	21.9% 7/32 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.7% 11/164 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders INJECTION SITE BRUISING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders MALAISE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders OEDEMA PERIPHERAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.9% 11/159 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	13.4% 22/164 • Number of events 34 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders PERIPHERAL SWELLING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.9% 11/159 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
General disorders PYREXIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	13.8% 22/159 • Number of events 35 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.9% 31/164 • Number of events 44 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	31.2% 10/32 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Immune system disorders SEASONAL ALLERGY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations BRONCHITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations CAMPYLOBACTER GASTROENTERITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations CELLULITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.5% 14/164 • Number of events 19 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations COVID-19	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.0% 8/159 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	17.7% 29/164 • Number of events 38 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	32.6% 14/43 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	30.2% 13/43 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.7% 3/18 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 2/11 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	42.9% 3/7 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	50.0% 1/2 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations CYSTITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations EYE INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations FOLLICULITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations FUNGAL SKIN INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations FURUNCLE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations GASTROENTERITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations HERPES ZOSTER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.6% 5/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations INFLUENZA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.3% 10/159 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.9% 13/164 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations LOCALISED INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations NASOPHARYNGITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.5% 12/159 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.9% 26/164 • Number of events 33 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.8% 8/31 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.6% 5/32 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations NOROVIRUS INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations ONYCHOMYCOSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations ORAL HERPES	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations OTITIS MEDIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PARONYCHIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.5% 14/164 • Number of events 23 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PHARYNGITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PNEUMONIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations PROSTATIC ABSCESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations RHINITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations SIALOADENITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations SINUSITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.3% 10/159 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 23/164 • Number of events 38 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	22.6% 7/31 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations SKIN INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations TINEA PEDIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations TOOTH INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	24.5% 39/159 • Number of events 50 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	44.5% 73/164 • Number of events 138 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	48.8% 21/43 • Number of events 44 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	51.2% 22/43 • Number of events 48 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	45.2% 14/31 • Number of events 24 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	34.4% 11/32 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 2/11 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.5% 12/159 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 23/164 • Number of events 40 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	19.4% 6/31 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Infections and infestations VIRAL INFECTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.1% 24/159 • Number of events 25 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	24.4% 40/164 • Number of events 63 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	27.9% 12/43 • Number of events 20 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	32.3% 10/31 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications EYE CONTUSION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications FALL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.1% 10/164 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications LIMB INJURY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications SCRATCH	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications SKIN ABRASION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications SKIN LACERATION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Injury, poisoning and procedural complications WOUND HAEMORRHAGE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.4% 17/164 • Number of events 33 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.7% 9/159 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.4% 17/164 • Number of events 24 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 20 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations BLOOD CREATININE INCREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.8% 16/164 • Number of events 20 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations BLOOD THYROID STIMULATING HORMONE DECREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.1% 16/159 • Number of events 38 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations PLATELET COUNT DECREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.0% 8/159 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations WEIGHT DECREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 19/164 • Number of events 23 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders ELECTROLYTE IMBALANCE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders GOUT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPERKALAEMIA	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.3% 12/164 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPERURICAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.5% 12/159 • Number of events 21 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 15/164 • Number of events 25 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.7% 11/164 • Number of events 20 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.4% 7/159 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders IRON DEFICIENCY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Metabolism and nutrition disorders VITAMIN B12 DEFICIENCY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	32.7% 52/159 • Number of events 84 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	50.0% 82/164 • Number of events 162 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	53.5% 23/43 • Number of events 48 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	46.5% 20/43 • Number of events 40 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	54.8% 17/31 • Number of events 28 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	50.0% 16/32 • Number of events 34 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.6% 20/159 • Number of events 22 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 42/164 • Number of events 57 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 11/43 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	32.3% 10/31 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	28.1% 9/32 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders FOOT DEFORMITY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders JOINT STIFFNESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	29.6% 47/159 • Number of events 66 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	26.2% 43/164 • Number of events 61 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	30.2% 13/43 • Number of events 20 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 11/43 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	32.3% 10/31 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	21.9% 7/32 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 2/11 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.5% 23/159 • Number of events 30 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.9% 31/164 • Number of events 46 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	22.6% 7/31 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 2/11 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.3% 12/164 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	13.2% 21/159 • Number of events 25 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.9% 31/164 • Number of events 39 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.8% 8/31 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.0% 8/32 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.7% 3/18 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders PERIARTHRITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Musculoskeletal and connective tissue disorders SPINAL PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.3% 12/164 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOCYTIC NAEVUS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders BRAIN FOG	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders CAROTID ARTERIOSCLEROSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders DIZZINESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	17.0% 27/159 • Number of events 34 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	19.5% 32/164 • Number of events 45 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders HEADACHE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	24.5% 39/159 • Number of events 55 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	31.7% 52/164 • Number of events 92 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	34.9% 15/43 • Number of events 27 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	41.9% 18/43 • Number of events 32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.8% 8/31 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	28.1% 9/32 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.2% 2/11 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders HYPOAESTHESIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.3% 12/164 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders MEMORY IMPAIRMENT	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders PARAESTHESIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.5% 14/164 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders SCIATICA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders SYNCOPE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Nervous system disorders TREMOR	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders AGITATION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders ANXIETY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.9% 13/164 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders DEPRESSION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.9% 8/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Psychiatric disorders INSOMNIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.8% 21/164 • Number of events 22 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	22.6% 7/31 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Renal and urinary disorders HAEMATURIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.7% 9/159 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.3% 12/164 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Renal and urinary disorders POLLAKIURIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Reproductive system and breast disorders HEAVY MENSTRUAL BLEEDING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Reproductive system and breast disorders TESTICULAR SWELLING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	17.6% 28/159 • Number of events 34 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	28.0% 46/164 • Number of events 63 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	34.9% 15/43 • Number of events 20 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	39.5% 17/43 • Number of events 25 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.8% 8/31 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	28.6% 2/7 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.9% 11/159 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	13.4% 22/164 • Number of events 25 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 11/43 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.0% 6/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.9% 19/159 • Number of events 27 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.3% 30/164 • Number of events 51 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.6% 8/43 • Number of events 17 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.0% 18/164 • Number of events 21 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.9% 4/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders NASAL DRYNESS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.7% 17/159 • Number of events 19 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.8% 39/164 • Number of events 63 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 15 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	29.0% 9/31 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	31.2% 10/32 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT CONGESTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.1% 10/164 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders ACNE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.7% 6/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders BLISTER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders BLOOD BLISTER	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.8% 6/159 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders DERMATITIS ACNEIFORM	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders DERMATITIS BULLOUS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.1% 16/159 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.2% 25/164 • Number of events 28 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.6% 5/32 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.3% 12/164 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.0% 8/159 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.9% 13/164 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.6% 5/32 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.3% 7/164 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders HYPERKERATOSIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.63% 1/159 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.61% 1/164 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders NAIL RIDGING	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.0% 5/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 15/164 • Number of events 18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders ONYCHOCLASIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	8.8% 14/159 • Number of events 14 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	13.4% 22/164 • Number of events 23 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders PETECHIAE	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.7% 17/159 • Number of events 23 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.2% 25/164 • Number of events 35 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	19.4% 6/31 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.0% 8/32 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	10.7% 17/159 • Number of events 19 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.8% 21/164 • Number of events 30 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.3% 7/43 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	4.7% 2/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.0% 8/32 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	14.3% 1/7 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.6% 1/18 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders RASH	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.3% 10/159 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 19/164 • Number of events 23 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.6% 5/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	18.8% 6/32 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.7% 9/159 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.9% 13/164 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.4% 3/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders RASH MACULAR	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.9% 3/159 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.5% 2/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 1/32 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	17.0% 27/159 • Number of events 32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	17.7% 29/164 • Number of events 38 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	20.9% 9/43 • Number of events 12 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	23.3% 10/43 • Number of events 11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	16.1% 5/31 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.6% 5/32 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders SKIN ATROPHY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders SKIN DISCOLOURATION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.5% 4/159 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.3% 1/43 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.7% 3/31 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders SKIN FISSURES	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.1% 5/159 • Number of events 6 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.5% 9/164 • Number of events 9 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders SKIN FRAGILITY	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.8% 3/164 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders SKIN LESION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	5.0% 8/159 • Number of events 8 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.9% 13/164 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	7.0% 3/43 • Number of events 3 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	3.2% 1/31 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	12.5% 4/32 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.1% 1/11 • Number of events 1 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Skin and subcutaneous tissue disorders SKIN MASS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.3% 2/159 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	2.4% 4/164 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	9.3% 4/43 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/32 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Vascular disorders HYPERTENSION	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	15.1% 24/159 • Number of events 33 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	27.4% 45/164 • Number of events 68 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	34.9% 15/43 • Number of events 26 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.6% 11/43 • Number of events 16 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	29.0% 9/31 • Number of events 13 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	25.0% 8/32 • Number of events 10 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	11.1% 2/18 • Number of events 5 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	45.5% 5/11 • Number of events 7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	42.9% 3/7 • Number of events 4 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.
Vascular disorders PHLEBITIS	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/164 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/159 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	1.2% 2/164 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/43 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/31 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	6.2% 2/32 • Number of events 2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/18 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/11 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/7 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.	0.00% 0/2 • From first dose until 30 days following last dose of study drug. Overall median treatment duration was 45.1 months for the MRD cohort and 13.8 months for the FD cohort.

Additional Information

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• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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