Trial Outcomes & Findings for ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas (NCT NCT01777152)

Last Updated: 2021-11-30

Results Overview

The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

452 participants

Primary outcome timeframe

Up to 60 months

Results posted on

2021-11-30

Participant Flow

Jan2013-Nov2016

Participant milestones

Participant milestones
Measure	A+CHP brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Study STARTED	226	226
Overall Study COMPLETED	131	116
Overall Study NOT COMPLETED	95	110

Reasons for withdrawal

Reasons for withdrawal
Measure	A+CHP brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Study Withdrawal by Subject	22	16
Overall Study Lost to Follow-up	3	5
Overall Study Death	68	89
Overall Study Not eligible, no study drug received	1	0
Overall Study Change of diagnosis	1	0

Baseline Characteristics

ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A+CHP n=226 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	Total n=452 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	157 Participants n=93 Participants	156 Participants n=4 Participants	313 Participants n=27 Participants
Age, Categorical >=65 years	69 Participants n=93 Participants	70 Participants n=4 Participants	139 Participants n=27 Participants
Age, Continuous	58 years n=93 Participants	58 years n=4 Participants	58 years n=27 Participants
Sex: Female, Male Female	93 Participants n=93 Participants	75 Participants n=4 Participants	168 Participants n=27 Participants
Sex: Female, Male Male	133 Participants n=93 Participants	151 Participants n=4 Participants	284 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=93 Participants	4 Participants n=4 Participants	14 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	186 Participants n=93 Participants	193 Participants n=4 Participants	379 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	30 Participants n=93 Participants	29 Participants n=4 Participants	59 Participants n=27 Participants
Race/Ethnicity, Customized Asian	45 Participants n=93 Participants	54 Participants n=4 Participants	99 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=93 Participants	6 Participants n=4 Participants	18 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized White	139 Participants n=93 Participants	142 Participants n=4 Participants	281 Participants n=27 Participants
Race/Ethnicity, Customized Other	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	26 Participants n=93 Participants	22 Participants n=4 Participants	48 Participants n=27 Participants
Region of Enrollment United States	70 Participants n=93 Participants	57 Participants n=4 Participants	127 Participants n=27 Participants
Region of Enrollment Japan	20 Participants n=93 Participants	23 Participants n=4 Participants	43 Participants n=27 Participants
Region of Enrollment South Korea	17 Participants n=93 Participants	23 Participants n=4 Participants	40 Participants n=27 Participants
Region of Enrollment Italy	17 Participants n=93 Participants	20 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment France	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Region of Enrollment Germany	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Region of Enrollment Spain	15 Participants n=93 Participants	11 Participants n=4 Participants	26 Participants n=27 Participants
Region of Enrollment Czechia	10 Participants n=93 Participants	12 Participants n=4 Participants	22 Participants n=27 Participants
Region of Enrollment United Kingdom	7 Participants n=93 Participants	14 Participants n=4 Participants	21 Participants n=27 Participants
Region of Enrollment Australia	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment Denmark	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment Israel	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment Hungary	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment Taiwan, Province Of China	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment Poland	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment Canada	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment Romania	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0	85 Participants n=93 Participants	93 Participants n=4 Participants	178 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1	90 Participants n=93 Participants	86 Participants n=4 Participants	176 Participants n=27 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2	51 Participants n=93 Participants	47 Participants n=4 Participants	98 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 60 months

Population: The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.

Outcome measures

Outcome measures
Measure	A+CHP n=226 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Progression-free Survival Per Independent Review Facility (IRF)	48.20 months Interval 8.87 to Insufficient number of participants experienced events	20.80 months Interval 4.7 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to 60 months

Population: This analysis population includes only patients with systemic anaplastic large cell lymphoma (sALCL).

Outcome measures

Outcome measures
Measure	A+CHP n=162 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=154 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)	55.66 months Interval 15.61 to Insufficient number of participants experienced events	32.03 months Interval 4.57 to Insufficient number of participants experienced events

SECONDARY outcome

Timeframe: Up to 8.34 months

Population: The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.

The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

Outcome measures

Outcome measures
Measure	A+CHP n=226 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)	153 Participants	126 Participants

SECONDARY outcome

Timeframe: Up to 90 months

The time from randomization to death due to any cause.

Outcome measures

Outcome measures
Measure	A+CHP n=226 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Overall Survival (OS)	NA Months Interval 0.0 to 86.5 The median and 75th percentile of OS was not reached in either treatment arm. The 25th percentile of OS in the A+CHP arm was 40.9 months as compared with 17.5 months in the CHOP arm.	NA Months Interval 0.1 to 90.0 The median and 75th percentile of OS was not reached in either treatment arm. The 25th percentile of OS in the A+CHP arm was 40.9 months as compared with 17.5 months in the CHOP arm.

SECONDARY outcome

Timeframe: Up to 8.34 months

Population: The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.

The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.

Outcome measures

Outcome measures
Measure	A+CHP n=226 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Objective Response Rate (ORR) Per IRF at End of Treatment	188 Participants	163 Participants

SECONDARY outcome

Timeframe: Up to 8.28 months

Population: The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	A+CHP n=223 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Incidence of Adverse Events (AEs) Any treatment-emergent AE	221 Participants	221 Participants
Incidence of Adverse Events (AEs) Blinded study treatment-related AE	201 Participants	193 Participants
Incidence of Adverse Events (AEs) CHP treatment-related AE	198 Participants	205 Participants
Incidence of Adverse Events (AEs) Any serious adverse event (SAE)	87 Participants	87 Participants
Incidence of Adverse Events (AEs) Blinded study treatment-related SAE	58 Participants	45 Participants
Incidence of Adverse Events (AEs) CHP treatment-related SAE	62 Participants	53 Participants
Incidence of Adverse Events (AEs) Treatment discontinuations due to AE	14 Participants	15 Participants
Incidence of Adverse Events (AEs) Treatment discontinuations due to blinded study treatment-related AE	10 Participants	10 Participants
Incidence of Adverse Events (AEs) Treatment discontinuations due to CHP treatment-related AE	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 8.28 months

Number of participants who experienced a Grade 3 or higher laboratory toxicity.

Outcome measures

Outcome measures
Measure	A+CHP n=223 Participants brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 Participants cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Incidence of Laboratory Abnormalities Leukocytes Low	12 Participants	21 Participants
Incidence of Laboratory Abnormalities Any Chemistry Test	25 Participants	23 Participants
Incidence of Laboratory Abnormalities Alanine Aminotransferase High	3 Participants	1 Participants
Incidence of Laboratory Abnormalities Albumin Low	2 Participants	3 Participants
Incidence of Laboratory Abnormalities Alkaline Phosphatase High	1 Participants	0 Participants
Incidence of Laboratory Abnormalities Calcium Low	1 Participants	1 Participants
Incidence of Laboratory Abnormalities Glucose High	8 Participants	6 Participants
Incidence of Laboratory Abnormalities Phosphate Low	4 Participants	3 Participants
Incidence of Laboratory Abnormalities Potassium High	0 Participants	2 Participants
Incidence of Laboratory Abnormalities Potassium Low	3 Participants	2 Participants
Incidence of Laboratory Abnormalities Sodium High	1 Participants	0 Participants
Incidence of Laboratory Abnormalities Sodium Low	4 Participants	6 Participants
Incidence of Laboratory Abnormalities Urate High	5 Participants	2 Participants
Incidence of Laboratory Abnormalities Any Hematology Test	68 Participants	78 Participants
Incidence of Laboratory Abnormalities Absolute Neutrophil Count Low	17 Participants	19 Participants
Incidence of Laboratory Abnormalities Hemoglobin High	1 Participants	0 Participants
Incidence of Laboratory Abnormalities Hemoglobin Low	9 Participants	13 Participants
Incidence of Laboratory Abnormalities Lymphocytes High	0 Participants	1 Participants
Incidence of Laboratory Abnormalities Lymphocytes Low	52 Participants	61 Participants
Incidence of Laboratory Abnormalities Neutrophils Low	17 Participants	19 Participants
Incidence of Laboratory Abnormalities Platelets Low	1 Participants	1 Participants

Adverse Events

A+CHP

Serious events: 89 serious events

Other events: 220 other events

Deaths: 67 deaths

CHOP

Serious events: 90 serious events

Other events: 218 other events

Deaths: 89 deaths

A+CHP Subgroup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Seagen Inc.

Phone: (855)473-2436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	A+CHP n=223 participants at risk brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 participants at risk cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	A+CHP Subgroup Includes only participants in A+CHP arm who were randomized but did not receive treatment.
Blood and lymphatic system disorders Febrile neutropenia	14.3% 32/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	11.5% 26/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Pneumonia	4.9% 11/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	1.3% 3/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Pyrexia	4.0% 9/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	3.5% 8/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Blood and lymphatic system disorders Neutropenia	3.6% 8/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	2.7% 6/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 5/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Sepsis	2.2% 5/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	1.8% 4/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Diarrhoea	1.8% 4/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	1.3% 3/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Renal and urinary disorders Acute kidney injury	1.3% 3/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Vascular disorders Deep vein thrombosis	1.3% 3/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.88% 2/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 3/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.88% 2/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Tumour lysis syndrome	1.3% 3/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Cellulitis	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Clostridium difficile colitis	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Dehydration	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	1.3% 3/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Device related infection	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Influenza	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Neutropenic infection	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.44% 1/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Nervous system disorders Peripheral sensory neuropathy	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Pneumocystis jirovecii pneumonia	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	2.7% 6/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Urinary tract infection	0.90% 2/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Abdominal pain	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.44% 1/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Abscess soft tissue	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Blood and lymphatic system disorders Anaemia	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.44% 1/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Anal fistula infection	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Asthenia	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Cardiac disorders Atrial fibrillation	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.44% 1/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Bacterial pyelonephritis	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Bacterial sepsis	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Musculoskeletal and connective tissue disorders Bone pain	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Bronchopulmonary aspergillosis	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Cardiac disorders Cardiac arrest	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.44% 1/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Catheter site cellulitis	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Clostridium difficile infection	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Constipation	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.44% 1/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Respiratory, thoracic and mediastinal disorders Cough	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Cytomegalovirus infection	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Decreased appetite	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Nervous system disorders Dizziness	0.45% 1/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.

Other adverse events
Measure	A+CHP n=223 participants at risk brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	CHOP n=226 participants at risk cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	A+CHP Subgroup Includes only participants in A+CHP arm who were randomized but did not receive treatment.
Blood and lymphatic system disorders Neutropenia	39.0% 87/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	35.8% 81/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Blood and lymphatic system disorders Anaemia	28.7% 64/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	21.7% 49/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Blood and lymphatic system disorders Thrombocytopenia	9.4% 21/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	6.2% 14/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Blood and lymphatic system disorders Leukopenia	8.1% 18/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.8% 13/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Blood and lymphatic system disorders Febrile neutropenia	7.2% 16/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	4.0% 9/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Endocrine disorders Hypothyroidism	5.4% 12/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	4.9% 11/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Nausea	51.1% 114/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	40.3% 91/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Constipation	43.9% 98/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	41.6% 94/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Diarrhoea	41.7% 93/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	24.3% 55/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Vomiting	26.9% 60/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	16.4% 37/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Stomatitis	12.6% 28/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	11.9% 27/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Abdominal pain	11.7% 26/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	9.7% 22/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.9% 22/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	7.1% 16/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Abdominal pain upper	10.3% 23/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	4.4% 10/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Dyspepsia	7.6% 17/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.3% 12/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Gastrointestinal disorders Haemorrhoids	3.6% 8/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.3% 12/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Fatigue	37.2% 83/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	35.4% 80/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Pyrexia	38.6% 86/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	32.7% 74/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Oedema peripheral	17.9% 40/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	15.9% 36/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Asthenia	15.7% 35/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	8.8% 20/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Mucosal inflammation	6.7% 15/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	6.2% 14/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Chest pain	6.3% 14/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	3.5% 8/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
General disorders Malaise	3.6% 8/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.3% 12/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Upper respiratory tract infection	8.1% 18/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.3% 12/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Nasopharyngitis	4.5% 10/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.3% 12/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Infections and infestations Urinary tract infection	5.4% 12/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	4.0% 9/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Investigations Weight decreased	24.2% 54/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	19.0% 43/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Investigations Alanine aminotransferase increased	4.9% 11/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	0.00% 0/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Decreased appetite	23.8% 53/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	20.8% 47/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Hypokalaemia	13.0% 29/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	10.6% 24/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Diabetes mellitus	6.3% 14/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.8% 13/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Hypercholesterolaemia	4.5% 10/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.3% 12/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Hyperlipidaemia	4.0% 9/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.8% 13/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Hyperglycaemia	4.9% 11/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	4.0% 9/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Metabolism and nutrition disorders Hyperuricaemia	4.9% 11/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	4.0% 9/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Musculoskeletal and connective tissue disorders Back pain	19.7% 44/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	19.0% 43/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Musculoskeletal and connective tissue disorders Arthralgia	13.9% 31/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	8.8% 20/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Musculoskeletal and connective tissue disorders Myalgia	12.1% 27/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	9.3% 21/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Musculoskeletal and connective tissue disorders Pain in extremity	10.3% 23/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	9.3% 21/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.
Musculoskeletal and connective tissue disorders Bone pain	6.7% 15/223 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	5.3% 12/226 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.	— 0/0 • Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.