Trial Outcomes & Findings for Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies (NCT NCT02118584)

NCT ID: NCT02118584

Last Updated: 2024-10-23

Results Overview

The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1822 participants
• Primary outcome timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks
• Results posted on: 2024-10-23

Participant Flow

Participants took part in this study in 42 countries. All participants who were enrolled in this study previously took part in one of the following parent studies - Phase II: GA27927; Phase III: GA28948, GA28949, GA28950, GA29102, GA29103.

This study consists of two parts, Part 1: Open-label extension (OLE) period and Part 2: Progressive multifocal leukoencephalopathy (PML) safety monitoring (SM) period. A total of 1822 participants with ulcerative colitis (UC) were enrolled in the study, 1773 participants in Part 1 and 796 participants in Part 2. Of the 796, 49 participants were directly enrolled into the Part 2: PML SM period from their respective parent studies.

Participant milestones

Measure	Part 1 (OLE): Etrolizumab Only Participants received etrolizumab 105 milligrams (mg), subcutaneously (SC) every 4 weeks (Q4W) for maximum of 369.9 weeks, followed by a 12-week safety follow-up.	Part 1 (OLE) to Part 2 (PML SM) Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up in the OLE period. After the OLE period, participants were given the option to enter Part 2 (PML SM). Participants who chose to enter the PML SM period were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.	Part 2 (PML SM) Only Participants from the Phase II or Phase III studies who were not eligible/did not wish to enroll in Part 1 (OLE), and had completed the 12-week safety follow-up period in their parent study were enrolled directly in Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.
Part 1: Open Label Extension Period STARTED	1026	747	0
Part 1: Open Label Extension Period COMPLETED	9	747	0
Part 1: Open Label Extension Period NOT COMPLETED	1017	0	0
Part 2: PML Safety Monitoring Period STARTED	0	747	49
Part 2: PML Safety Monitoring Period COMPLETED	0	317	43
Part 2: PML Safety Monitoring Period NOT COMPLETED	0	430	6

Reasons for withdrawal

Measure	Part 1 (OLE): Etrolizumab Only Participants received etrolizumab 105 milligrams (mg), subcutaneously (SC) every 4 weeks (Q4W) for maximum of 369.9 weeks, followed by a 12-week safety follow-up.	Part 1 (OLE) to Part 2 (PML SM) Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up in the OLE period. After the OLE period, participants were given the option to enter Part 2 (PML SM). Participants who chose to enter the PML SM period were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.	Part 2 (PML SM) Only Participants from the Phase II or Phase III studies who were not eligible/did not wish to enroll in Part 1 (OLE), and had completed the 12-week safety follow-up period in their parent study were enrolled directly in Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.
Part 1: Open Label Extension Period Adverse Event	79	0	0
Part 1: Open Label Extension Period Death	9	0	0
Part 1: Open Label Extension Period Lost to Follow-up	53	0	0
Part 1: Open Label Extension Period Non-compliance	12	0	0
Part 1: Open Label Extension Period Other	3	0	0
Part 1: Open Label Extension Period Physician Decision	128	0	0
Part 1: Open Label Extension Period Protocol Violation	1	0	0
Part 1: Open Label Extension Period Study Terminated by Sponsor	29	0	0
Part 1: Open Label Extension Period Withdrawal by Subject	568	0	0
Part 2: PML Safety Monitoring Period Adverse Event	0	5	0
Part 2: PML Safety Monitoring Period Death	0	1	0
Part 2: PML Safety Monitoring Period Lost to Follow-up	0	22	3
Part 2: PML Safety Monitoring Period Non-Compliance	0	0	1
Part 2: PML Safety Monitoring Period Reason Not Specified	0	6	0
Part 2: PML Safety Monitoring Period Physician Decision	0	10	1
Part 2: PML Safety Monitoring Period Study Terminated by Sponsor	0	354	0
Part 2: PML Safety Monitoring Period Withdrawal by Subject	0	32	1

Baseline Characteristics

Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

Baseline characteristics by cohort

Measure	Part 1 (OLE): Etrolizumab Only n=1026 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.	Part 1 (OLE) to Part 2 (PML SM) n=747 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up in the OLE period. After the OLE period, participants were given the option to enter Part 2 (PML SM). Participants who chose to enter the PML SM period were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.	Part 2 (PML SM) Only n=49 Participants Participants from the Phase II or Phase III studies who were not eligible/did not wish to enroll in Part 1 (OLE), and had completed the 12-week safety follow-up period in their parent study were enrolled directly in Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.	Total n=1822 Participants Total of all reporting groups
Age, Continuous	39.7 years STANDARD_DEVIATION 13.3 • n=5 Participants	40.7 years STANDARD_DEVIATION 14.1 • n=7 Participants	42.7 years STANDARD_DEVIATION 15.2 • n=5 Participants	40.2 years STANDARD_DEVIATION 13.7 • n=4 Participants
Sex: Female, Male Female	417 Participants n=5 Participants	333 Participants n=7 Participants	23 Participants n=5 Participants	773 Participants n=4 Participants
Sex: Female, Male Male	609 Participants n=5 Participants	414 Participants n=7 Participants	26 Participants n=5 Participants	1049 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	59 Participants n=5 Participants	93 Participants n=7 Participants	0 Participants n=5 Participants	152 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	915 Participants n=5 Participants	632 Participants n=7 Participants	47 Participants n=5 Participants	1594 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	52 Participants n=5 Participants	22 Participants n=7 Participants	2 Participants n=5 Participants	76 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Asian	101 Participants n=5 Participants	40 Participants n=7 Participants	4 Participants n=5 Participants	145 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized White	843 Participants n=5 Participants	635 Participants n=7 Participants	40 Participants n=5 Participants	1518 Participants n=4 Participants
Race/Ethnicity, Customized Other	36 Participants n=5 Participants	32 Participants n=7 Participants	2 Participants n=5 Participants	70 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	33 Participants n=5 Participants	20 Participants n=7 Participants	2 Participants n=5 Participants	55 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324 weeks

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.

The pMCS is a composite of 3 assessments, each rated from 0 (none) to 3 (severe disease): stool frequency, rectal bleeding, and physician's global assessment. The total score for pMCS ranges from 0 (none) to 9 (severe disease). pMCS clinical remission was defined as pMCS ≤ 2, a rectal bleeding score of 0-1, physician's global assessment of 0-1, stool frequency subscore of 0-1. Percentages have been rounded off.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1772 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 12	55.9 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 60	72.2 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 72	75.4 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 84	76.5 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 156	78.5 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 180	78.8 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 192	80.8 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 264	84.8 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 276	86.0 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 324	80.0 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Baseline	32.0 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 4	47.2 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 8	52.2 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 24	63.7 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 36	68.3 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 48	73.4 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 96	77.2 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 108	72.0 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 120	77.4 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 132	82.2 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 144	80.0 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 168	81.0 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 204	83.6 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 216	84.8 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 228	85.1 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 240	82.6 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 252	86.0 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 288	82.4 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 300	86.7 percentage of participants
Part 1: Percentage of Participants With Clinical Remission as Determined by the Partial Mayo Clinic Score (pMCS) Week 312	87.1 percentage of participants

PRIMARY outcome

Timeframe: At OLE Week 108

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis.

The Mayo Clinic scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). MCS remission was defined as MCS ≤ 2, a rectal bleeding score of 0, physician's global assessment of 0-1, stool frequency subscore of 0-1 and endoscopy score of 0-1. Percentage has been rounded off.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=623 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Percentage of Participants With Remission as Determined by the Mayo Clinic Score (MCS)	58.1 percentage of participants

PRIMARY outcome

Timeframe: At OLE Week 108

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. Overall number analyzed is the number of participants with data available for analysis.

The Mayo scoring system is a composite of 4 assessments for UC disease activity. The 4 component sub-scores are: 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment, each rated from 0-3, 0 representing no pathology to 3 for severe disease. The minimum Mayo Score is 0 (no pathology) and the maximum is 12 (severe disease). Endoscopic remission was defined as Mayo Endoscopic subscore = 0. Percentage has been rounded off.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=900 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Percentage of Participants With Endoscopic Remission	45.7 percentage of participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] Grade 2 AEs	679 Participants
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] Any AEs	1431 Participants
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] Grade 1 AEs	315 Participants
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] Grade 3 AEs	405 Participants
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] Grade 4 AEs	23 Participants
Part 1: Number of Participants With Adverse Events (AEs) and Severity of AEs Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.0] Grade 5 AEs	9 Participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigation, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With Serious Adverse Events (SAEs)	373 Participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

An AE is any untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were graded as per NCI CTCAE v4.0. Grade 1= Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to adverse event.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 Infection Related AEs, Grade 1	576 Participants
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 Infection Related AEs, Grade 5	1 Participants
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 Infection Related AEs, Grade 2	423 Participants
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 Infection Related AEs, Grade 3	96 Participants
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 Infection Related AEs, Grade 4	6 Participants
Part 1: Number of Participants With Infection Related AEs and Severity of Infection-Related AEs Assessed Using NCI CTCAE v4.0 Infection Related AEs, Any Grade	825 Participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With Serious Infection Related AES	110 Participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Injection-site reaction=any local reaction occurring at the site of injection following study drug administration. Signs (e.g., erythema, induration/swelling at injection site) and symptoms (e.g., pain, pruritus at injection site). Injection site reactions. were graded as per NCI CTCAE v4.0. Grade 1=Tenderness with or without associated symptoms (e.g., warmth, erythema, itching); Grade 2=Pain; lipodystrophy; edema; phlebitis; Grade 3=Ulceration or necrosis; severe tissue damage; operative intervention indicated; Grade 4=life-threatening consequences or urgent intervention indicated; Grade=5 death related to AE.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 Injection Site Reactions, Any Grade	32 Participants
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 Injection Site Reactions, Grade 1	28 Participants
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 Injection Site Reactions, Grade 3	0 Participants
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 Injection Site Reactions, Grade 4	0 Participants
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 Injection Site Reactions, Grade 5	0 Participants
Part 1: Number of Participants With Injection Site Reactions and Severity of Injection Site Reactions Assessed Using NCI CTCAE v4.0 Injection Site Reactions, Grade 2	5 Participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a Etrolizumab, whether or not considered related to the medicinal (investigational) product. Number of participants who discontinued etrolizumab treatment during the OLE period have been reported here.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With AEs Leading to Etrolizumab Discontinuation	234 Participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Number of participants who developed malignancies during the OLE period have been reported here.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With Malignancies	38 Participants

PRIMARY outcome

Timeframe: From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years)

Population: OLE Population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study.

AE=untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. Hypersensitivity was assessed as per NCI CTCAE v4.0. Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=1773 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 Hypersensitivity Reactions, Any Grade	85 Participants
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 Hypersensitivity Reactions, Grade 1	65 Participants
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 Hypersensitivity Reactions, Grade 2	19 Participants
Part 1: Number of Participants With Hypersensitivity Reactions and Severity of Hypersensitivity Assessed Using NCI-CTCAE v4.0 Hypersensitivity Reactions, Grade 3	4 Participants

PRIMARY outcome

Timeframe: From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks

Population: PML Safety Monitoring population included all participants who entered the PML SM period. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.

Outcome measures

Measure	Part 1 (OLE): Etrolizumab n=796 Participants Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.
Part 2: Number of Participants With Confirmed Progressive Multifocal Leukoencephalopathy (PML) During the Post-Treatment PML Monitoring Period	0 Participants

Adverse Events

Part 1 (OLE): Etrolizumab

Serious events: 373 serious events

Other events: 1052 other events

Deaths: 9 deaths

Part 2 (PML SM)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Part 1 (OLE): Etrolizumab n=1773 participants at risk Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.	Part 2 (PML SM) n=796 participants at risk Participants from Part 1 (OLE) and from Phase II/III studies who were not eligible/did not wish to enroll in Part 1 (OLE) and had completed the 12-week safety follow-up period were enrolled in the Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.
Blood and lymphatic system disorders Anaemia	0.90% 16/1773 • Number of events 19 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Blood and lymphatic system disorders Haemolytic anaemia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Blood and lymphatic system disorders Iron deficiency anaemia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Blood and lymphatic system disorders Leukaemoid reaction	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Blood and lymphatic system disorders Lymphadenopathy	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Blood and lymphatic system disorders Pancytopenia	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Acute coronary syndrome	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Acute myocardial infarction	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Angina pectoris	0.23% 4/1773 • Number of events 4 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Angina unstable	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Atrial fibrillation	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Atrioventricular block complete	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Cardiac arrest	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Cardiac failure congestive	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Coronary artery occlusion	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Coronary artery stenosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Myocardial infarction	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Palpitations	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Cardiac disorders Paroxysmal atrioventricular block	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Congenital, familial and genetic disorders Heart disease congenital	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Congenital, familial and genetic disorders Tethered oral tissue	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Ear and labyrinth disorders Vertigo	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Eye disorders Retinal detachment	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Abdominal pain	0.34% 6/1773 • Number of events 6 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Abdominal pain lower	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Abdominal pain upper	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Anal fistula	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Autoimmune pancreatitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Colitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Colitis ulcerative	7.4% 131/1773 • Number of events 153 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.13% 1/796 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Colon dysplasia	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Colonic fistula	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Diarrhoea	0.23% 4/1773 • Number of events 4 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Dyspepsia	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Food poisoning	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Gastrointestinal dysplasia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Gastrointestinal polyp	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Haemorrhoids thrombosed	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Inguinal hernia	0.28% 5/1773 • Number of events 5 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Intestinal haemorrhage	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Intestinal polyp	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Irritable bowel syndrome	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Large intestine polyp	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Malocclusion	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Nausea	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Pancreatitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Pancreatitis acute	0.11% 2/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Pancreatitis chronic	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Proctitis	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Rectal haemorrhage	0.11% 2/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Small intestinal obstruction	0.11% 2/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Strangulated umbilical hernia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Vomiting	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
General disorders Chest pain	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
General disorders Drug withdrawal syndrome	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
General disorders Hyperthermia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
General disorders Inflammation	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
General disorders Pyrexia	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
General disorders Sudden cardiac death	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
General disorders Sudden death	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Hepatobiliary disorders Biliary colic	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Hepatobiliary disorders Cholecystitis acute	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Hepatobiliary disorders Cholelithiasis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Hepatobiliary disorders Hepatic cirrhosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Abdominal sepsis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Abscess	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Acute sinusitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Anal abscess	0.39% 7/1773 • Number of events 7 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Appendiceal abscess	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Appendicitis	0.62% 11/1773 • Number of events 11 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Bacterial infection	0.11% 2/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Bacterial salpingitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Bone abscess	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Bronchitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations COVID-19	0.73% 13/1773 • Number of events 13 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.13% 1/796 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations COVID-19 pneumonia	0.23% 4/1773 • Number of events 4 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Campylobacter gastroenteritis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Cellulitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Clostridium difficile colitis	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Clostridium difficile infection	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Complicated appendicitis	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Coronavirus infection	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Cystitis	0.06% 1/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Cytomegalovirus colitis	0.17% 3/1773 • Number of events 4 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Cytomegalovirus infection	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Disseminated tuberculosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Diverticulitis	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Endometritis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Epstein-Barr virus infection	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Erysipelas	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Focal peritonitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Folliculitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Gastroenteritis	0.34% 6/1773 • Number of events 6 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Gastroenteritis norovirus	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Gastroenteritis salmonella	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Gastroenteritis viral	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Gastrointestinal infection	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Gastrointestinal viral infection	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Influenza	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Large intestine infection	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Latent tuberculosis	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Lower respiratory tract infection	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Meningitis listeria	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Neutropenic sepsis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Otitis media	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Peritonitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Peritonsillar abscess	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Pneumonia	0.56% 10/1773 • Number of events 10 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Pyelonephritis	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Rectal abscess	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Respiratory syncytial virus infection	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Salmonellosis	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Sinusitis	0.06% 1/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Tuberculous pleurisy	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Urosepsis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Ankle fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Arthropod bite	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Clavicle fracture	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Concussion	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Contusion	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Craniofacial fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Epidural haemorrhage	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Epiphyseal fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Exposure to communicable disease	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Fall	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Femur fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Foot fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Fracture displacement	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Hand fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Head injury	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Hip fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Injury	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Joint dislocation	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Joint injury	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Ligament sprain	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Muscle strain	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Periprocedural myocardial infarction	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Procedural pain	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Pulmonary contusion	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Radius fracture	0.11% 2/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Road traffic accident	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Shoulder fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Spondylolysis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Sternal fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Tibia fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Uterine perforation	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Injury, poisoning and procedural complications Wrist fracture	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Investigations Blood creatine phosphokinase increased	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Investigations Blood lactate dehydrogenase increased	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Investigations Cytomegalovirus test positive	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Investigations Hepatic enzyme increased	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Investigations Influenza A virus test positive	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Metabolism and nutrition disorders Dehydration	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Metabolism and nutrition disorders Hyperglycaemia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Metabolism and nutrition disorders Hyponatraemia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Metabolism and nutrition disorders Obesity	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Arthritis	0.11% 2/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Arthropathy	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Flank pain	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Muscular weakness	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Seronegative arthritis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Tendon laxity	0.06% 1/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary breast neoplasm	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian stromal cancer	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour perforation	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Dizziness	0.00% 0/1773 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.13% 1/796 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Headache	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Ischaemic stroke	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Multiple sclerosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Sciatica	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Seizure	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Syncope	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Transient ischaemic attack	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Pregnancy, puerperium and perinatal conditions Abortion	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Product Issues Device dislocation	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Psychiatric disorders Post-traumatic stress disorder	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Acute kidney injury	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Bladder perforation	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Glomerulonephritis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Hydronephrosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Nephrolithiasis	0.56% 10/1773 • Number of events 14 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Pelvi-ureteric obstruction	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Renal colic	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Ureterolithiasis	0.28% 5/1773 • Number of events 6 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Renal and urinary disorders Urinary tract obstruction	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Abnormal uterine bleeding	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Acquired hydrocele	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Cervical dysplasia	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Cervical polyp	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Endometriosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Ovarian cyst	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Paraphimosis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Pelvic pain	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Reproductive system and breast disorders Uterine haemorrhage	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Skin and subcutaneous tissue disorders Angioedema	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Skin and subcutaneous tissue disorders Erythema	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Skin and subcutaneous tissue disorders Erythema nodosum	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Skin and subcutaneous tissue disorders Granuloma skin	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Vascular disorders Deep vein thrombosis	0.17% 3/1773 • Number of events 3 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Vascular disorders Hypotension	0.06% 1/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Vascular disorders Phlebitis	0.06% 1/1773 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Vascular disorders Thrombosis	0.11% 2/1773 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Vascular disorders Orthostatic hypotension	0.00% 0/1773 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.13% 1/796 • Number of events 1 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.

Other adverse events

Measure	Part 1 (OLE): Etrolizumab n=1773 participants at risk Participants received etrolizumab 105 mg, SC, Q4W for maximum of 369.9 weeks, followed by a 12-week safety follow-up.	Part 2 (PML SM) n=796 participants at risk Participants from Part 1 (OLE) and from Phase II/III studies who were not eligible/did not wish to enroll in Part 1 (OLE) and had completed the 12-week safety follow-up period were enrolled in the Part 2 (PML SM). Participants were monitored for PML for a maximum of 92-weeks, during which no etrolizumab treatment was administered.
Blood and lymphatic system disorders Anaemia	7.2% 128/1773 • Number of events 149 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Abdominal pain	5.5% 98/1773 • Number of events 117 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Colitis ulcerative	33.1% 587/1773 • Number of events 882 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.25% 2/796 • Number of events 2 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Gastrointestinal disorders Diarrhoea	5.4% 95/1773 • Number of events 114 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations COVID-19	9.3% 165/1773 • Number of events 178 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Influenza	5.6% 100/1773 • Number of events 121 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Nasopharyngitis	12.7% 226/1773 • Number of events 344 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Infections and infestations Upper respiratory tract infection	6.2% 110/1773 • Number of events 157 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Musculoskeletal and connective tissue disorders Arthralgia	7.2% 128/1773 • Number of events 172 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.
Nervous system disorders Headache	7.6% 134/1773 • Number of events 187 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.	0.00% 0/796 • Part 1 (OLE): From Day 1 up to end of 12-week safety follow up in OLE (approximately 7 years); Part 2 (PML SM): From end of safety follow-up in Part 1 or Phase II/III parent studies up to a maximum of 92 weeks OLE population included all participants who received at least one dose of open label etrolizumab in Part 1 of the study. PML SM population included all participants who entered the PML SM period. Part 2: PML SM arm includes all participants who entered PML SM from Part 1 (OLE) and from their respective parent studies. No treatment was administered in PML SM period, and hence participants entering from Part 1 (OLE) and the parent studies have been reported together.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER