Trial Outcomes & Findings for A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma (NCT NCT00420849)

NCT ID: NCT00420849

Last Updated: 2012-05-21

Results Overview

Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 587 participants
• Primary outcome timeframe: up to 123 weeks
• Results posted on: 2012-05-21

Participant Flow

Participant milestones

Measure	Lenalidomide Plus Dexamethasone Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Study STARTED	587
Overall Study COMPLETED	256
Overall Study NOT COMPLETED	331

Reasons for withdrawal

Measure	Lenalidomide Plus Dexamethasone Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Study Lack of Efficacy	154
Overall Study Adverse Event	107
Overall Study Withdrawal by Subject	28
Overall Study Death	18
Overall Study Other	14
Overall Study Transplant	8
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

Baseline characteristics by cohort

Measure	Lenalidomide Plus Dexamethasone n=587 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Age Continuous	64.5 years STANDARD_DEVIATION 9.74 • n=5 Participants
Age, Customized <=18 years	0 participants n=5 Participants
Age, Customized >18 and <=65 years	314 participants n=5 Participants
Age, Customized >65 years	273 participants n=5 Participants
Sex: Female, Male Female	241 Participants n=5 Participants
Sex: Female, Male Male	346 Participants n=5 Participants
Race/Ethnicity, Customized White	548 participant n=5 Participants
Race/Ethnicity, Customized Other	17 participant n=5 Participants
Race/Ethnicity, Customized Asian / Pacific Islander	10 participant n=5 Participants
Race/Ethnicity, Customized Black	9 participant n=5 Participants
Race/Ethnicity, Customized Hispanic	3 participant n=5 Participants

PRIMARY outcome

Timeframe: up to 123 weeks

Population: Safety population

Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.

National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=587 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment At least one TEAE related to study drug	519 participants	—	—
Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment At least one TEAE with severity grade of 3 or 4	471 participants	—	—
Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment At least one serious AE (SAE)	340 participants	—	—
Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment At least one treatment-emergent AE (TEAE)	586 participants	—	—

SECONDARY outcome

Timeframe: up to 124 weeks

Population: Safety population

Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=587 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Participants With Adverse Events of Special Interest: Peripheral Neuropathy At least one TEAE of peripheral neuropathy	84 participants	—	—
Participants With Adverse Events of Special Interest: Peripheral Neuropathy Neuropathy peripheral	46 participants	—	—
Participants With Adverse Events of Special Interest: Peripheral Neuropathy Peripheral sensory neuropathy	33 participants	—	—
Participants With Adverse Events of Special Interest: Peripheral Neuropathy Neuralgia	5 participants	—	—
Participants With Adverse Events of Special Interest: Peripheral Neuropathy Peripheral motor neuropathy	2 participants	—	—
Participants With Adverse Events of Special Interest: Peripheral Neuropathy Polyneuropathy	2 participants	—	—
Participants With Adverse Events of Special Interest: Peripheral Neuropathy Sensory disturbance	1 participants	—	—

SECONDARY outcome

Timeframe: up to 124 weeks

Population: Safety population

Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=587 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)	25.6 weeks Standard Deviation 21.53	—	—

SECONDARY outcome

Timeframe: up to 124 weeks

Population: Safety population

Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=587 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Participants With Adverse Events of Special Interest: Venous Thromboembolic Events Thrombophlebitis	7 participants	—	—
Participants With Adverse Events of Special Interest: Venous Thromboembolic Events At least one venous thromboembolic event	60 participants	—	—
Participants With Adverse Events of Special Interest: Venous Thromboembolic Events Deep vein thrombosis	38 participants	—	—
Participants With Adverse Events of Special Interest: Venous Thromboembolic Events Pulmonary embolism	23 participants	—	—
Participants With Adverse Events of Special Interest: Venous Thromboembolic Events Venous thrombosis limb	1 participants	—	—

SECONDARY outcome

Timeframe: up to 124 weeks

Population: Safety population

Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=587 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)	26.5 weeks Standard Deviation 21.51	—	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=153 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale	-3.6 units on a scale Standard Deviation 16.19	-2.9 units on a scale Standard Deviation 16.54	-1.8 units on a scale Standard Deviation 15.10

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=122 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale	-2.4 units on a scale Standard Deviation 26.05	-1.5 units on a scale Standard Deviation 32.50	-2.6 units on a scale Standard Deviation 31.61

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=151 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale	-0.2 units on a scale Standard Deviation 15.92	-4.0 units on a scale Standard Deviation 19.17	-0.7 units on a scale Standard Deviation 27.32

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale	-1.9 units on a scale Standard Deviation 19.61	-4.9 units on a scale Standard Deviation 23.06	3.5 units on a scale Standard Deviation 16.96

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale	-5.2 units on a scale Standard Deviation 26.25	-5.3 units on a scale Standard Deviation 29.67	-3.1 units on a scale Standard Deviation 30.72

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale	2.6 units on a scale Standard Deviation 20.93	5.3 units on a scale Standard Deviation 26.59	1.0 units on a scale Standard Deviation 22.07

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=153 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=125 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale	-3.9 units on a scale Standard Deviation 25.56	-5.2 units on a scale Standard Deviation 28.35	-6.6 units on a scale Standard Deviation 32.77

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale	1.0 units on a scale Standard Deviation 13.99	0.1 units on a scale Standard Deviation 17.14	-2.2 units on a scale Standard Deviation 19.82

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=150 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale	1.1 units on a scale Standard Deviation 31.71	7.9 units on a scale Standard Deviation 26.68	2.6 units on a scale Standard Deviation 37.47

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=151 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=37 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale	8.6 units on a scale Standard Deviation 24.18	8.1 units on a scale Standard Deviation 24.27	9.0 units on a scale Standard Deviation 24.40

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=151 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=37 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale	-3.8 units on a scale Standard Deviation 29.70	2.2 units on a scale Standard Deviation 35.38	-1.8 units on a scale Standard Deviation 34.20

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=148 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=122 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale	2.7 units on a scale Standard Deviation 25.94	2.7 units on a scale Standard Deviation 27.97	-0.9 units on a scale Standard Deviation 28.46

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=123 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=37 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale	0.4 units on a scale Standard Deviation 27.12	3.3 units on a scale Standard Deviation 30.60	-4.5 units on a scale Standard Deviation 29.57

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=121 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale	2.0 units on a scale Standard Deviation 20.74	0.8 units on a scale Standard Deviation 22.14	0.9 units on a scale Standard Deviation 16.42

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=152 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=122 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale	1.1 units on a scale Standard Deviation 20.90	-1.8 units on a scale Standard Deviation 23.17	-2.2 units on a scale Standard Deviation 21.81

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=151 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=122 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=37 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale	-2.4 units on a scale Standard Deviation 16.79	-1.2 units on a scale Standard Deviation 17.62	-3.9 units on a scale Standard Deviation 19.00

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=151 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=121 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=37 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale	4.9 units on a scale Standard Deviation 13.22	4.7 units on a scale Standard Deviation 13.16	2.0 units on a scale Standard Deviation 13.45

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=150 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=119 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale	5.8 units on a scale Standard Deviation 21.14	3.4 units on a scale Standard Deviation 21.70	4.4 units on a scale Standard Deviation 21.85

SECONDARY outcome

Timeframe: Baseline (Day 0), Week 24

Population: Full analysis set of participants who completed the questionnaire at baseline and week 24.

EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.

Outcome measures

Measure	Lenalidomide Plus Dexamethasone n=149 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.	Lenalidomide - Subpopulation From UK + Ireland n=117 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.	Lenalidomide - Subpopulation From Spain n=38 Participants Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale	-4.3 units on a scale Standard Deviation 35.15	-2.0 units on a scale Standard Deviation 33.42	-5.3 units on a scale Standard Deviation 31.51

Adverse Events

Lenalidomide Plus Dexamethasone

Serious events: 340 serious events

Other events: 579 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lenalidomide Plus Dexamethasone n=587 participants at risk Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Infections and infestations Febrile infection	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Oral candidiasis	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Pneumocystis jiroveci pneumonia	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Staphylococcal sepsis	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Abscess limb	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Abscess oral	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Anal infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Appendicitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bacterial infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Brain abscess	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bronchiolitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bronchitis moraxella	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Catheter related infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Cellulitis staphylococcal	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Central line infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Cholecystitis infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Clostridial infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Diverticulitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Endocarditis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Escherichia urinary tract infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Eye infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Fungal infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Gastroenteritis viral	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Herpes zoster	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Herpes zoster disseminated	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Influenza	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Joint abscess	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Legionella infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Listeria sepsis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Localised infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Meningitis streptococcal	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Necrotising fasciitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bronchitis acute	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Opportunistic infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Orchitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Parotitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Perianal abscess	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Pilonidal cyst	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Pneumonia legionella	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Pneumonia moraxella	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Pneumonia staphylococcal	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Pseudomonal bacteraemia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Staphylococcal bacteraemia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Subacute endocarditis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Tooth abscess	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Tooth infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Urosepsis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Anaemia	5.3% 31/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Febrile neutropenia	3.7% 22/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Neutropenia	2.7% 16/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Thrombocytopenia	1.9% 11/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Pancytopenia	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Leukopenia	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Coagulopathy	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Haemolytic anaemia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Lymphopenia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Pyrexia	5.1% 30/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Fatigue	1.5% 9/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Oedema peripheral	1.0% 6/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders General physical health deterioration	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Non-cardiac chest pain	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Pain	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Asthenia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Chest pain	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Death	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Disease progression	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Drug interaction	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Hyperplasia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Malaise	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Multi-organ failure	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Sudden death	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Neutropenic infection	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.7% 22/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 8/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Asthma	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Bronchial hyperactivity	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Cough	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Arthritis bacterial	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bacteraemia	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bacterial sepsis	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bronchopneumonia	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Pneumonia	8.9% 52/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Lower respiratory tract infection	6.5% 38/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Sepsis	2.9% 17/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Respiratory tract infection	2.6% 15/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Cellulitis	2.4% 14/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Infection	1.2% 7/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Neutropenic sepsis	1.0% 6/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Upper respiratory tract infection	1.0% 6/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Urinary tract infection	1.0% 6/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Lobar pneumonia	0.85% 5/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Septic shock	0.85% 5/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Bronchitis	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Gastroenteritis	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Lung infection pseudomonal	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Productive cough	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	6.6% 39/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma of skin	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloma recurrence	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Back pain	1.9% 11/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Muscular weakness	1.5% 9/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Arthralgia	0.85% 5/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Bone pain	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Myopathy	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Pain in extremity	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Fistula	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Groin pain	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Neck pain	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Pathological fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Deep vein thrombosis	4.3% 25/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Hypotension	0.85% 5/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Orthostatic hypotension	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Arterial thrombosis limb	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Circulatory collapse	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Embolism	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Hypertension	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Phlebitis superficial	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Shock	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Thrombosis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Vascular disorders Vasculitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Atrial fibrillation	2.0% 12/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Cardiac failure	1.2% 7/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Acute myocardial infarction	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Angina unstable	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Angina pectoris	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Atrial flutter	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Cardio-respiratory arrest	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Left ventricular failure	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Acute coronary syndrome	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Atrial thrombosis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Bradycardia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Cardiac failure congestive	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Cardiopulmonary failure	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Myocardial infarction	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Myocardial ischaemia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Supraventricular tachycardia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Cardiac disorders Tachycardia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Renal failure acute	2.7% 16/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Renal failure	1.4% 8/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Renal impairment	1.2% 7/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Bladder disorder	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Haematuria	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Obstructive uropathy	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Proteinuria	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Renal failure chronic	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Renal mass	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Renal tubular acidosis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Renal and urinary disorders Urinary retention	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Dizziness	0.85% 5/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Syncope	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Lethargy	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Syncope vasovagal	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Transient ischaemic attack	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Cerebrovascular accident	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Loss of consciousness	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Somnolence	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Spinal cord compression	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Tremor	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Cerebral haemorrhage	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Convulsion	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Cranial nerve paralysis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Encephalopathy	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Neuralgia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Phantom pain	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Polyneuropathy	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Serotonin syndrome	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Diarrhoea	1.2% 7/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Abdominal pain	0.85% 5/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Vomiting	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Intestinal obstruction	0.51% 3/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Rectal haemorrhage	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Abdominal pain lower	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Abdominal pain upper	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Abdominal strangulated hernia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Diverticular perforation	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Dyspepsia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Enterovesical fistula	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Gastritis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Haematemesis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Intestinal perforation	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Large intestinal obstruction	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Large intestine perforation	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Nausea	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Oesophageal haemorrhage	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Oesophagitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Pancreatitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Pancreatitis acute	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Peritonitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Retroperitoneal haematoma	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Small intestinal obstruction	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Dehydration	2.4% 14/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hyperglycaemia	1.4% 8/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hypercalcaemia	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hypocalcaemia	0.68% 4/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hypokalaemia	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Fluid overload	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hypoalbuminaemia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hypophosphataemia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Tetany	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Vitamin D deficiency	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Fall	0.85% 5/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Accidental overdose	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Femur fracture	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Humerus fracture	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Compression fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Drug toxicity	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Femoral neck fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Foreign body trauma	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Head injury	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Jaw fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Lower limb fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Multiple fractures	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Muscle rupture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Radius fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Rib fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Road traffic accident	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Spinal compression fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Injury, poisoning and procedural complications Wrist fracture	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Confusional state	2.2% 13/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Agitation	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Depression	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Hallucination	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Korsakoff's psychosis alcoholic	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Panic attack	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Psychotic disorder	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Blood creatinine increased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations International normalised ratio increased	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Blood alkaline phosphatase increased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Blood bilirubin increased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Blood calcium decreased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Blood creatine phosphokinase increased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Blood culture positive	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Gamma-glutamyltransferase increased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Hepatic enzyme increased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Prostatic specific antigen increased	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Endocrine disorders Steroid withdrawal syndrome	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Endocrine disorders Hyperparathyroidism	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Endocrine disorders Hyperthyroidism	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Hepatobiliary disorders Cholecystitis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Hepatobiliary disorders Cholelithiasis	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Hepatobiliary disorders Hepatic failure	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Hepatobiliary disorders Hepatic function abnormal	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Reproductive system and breast disorders Oedema genital	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Reproductive system and breast disorders Pelvic pain	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Skin and subcutaneous tissue disorders Rash	0.34% 2/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Eye disorders Vision blurred	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Immune system disorders Drug hypersensitivity	0.17% 1/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.

Other adverse events

Measure	Lenalidomide Plus Dexamethasone n=587 participants at risk Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
General disorders Fatigue	42.4% 249/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Neutropenia	41.4% 243/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Muscle spasms	34.4% 202/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Constipation	33.0% 194/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Diarrhoea	30.7% 180/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Insomnia	29.5% 173/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Anaemia	26.2% 154/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Blood and lymphatic system disorders Thrombocytopenia	21.3% 125/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Tremor	19.3% 113/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Oedema peripheral	17.2% 101/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Nausea	16.7% 98/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.4% 96/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Upper respiratory tract infection	15.7% 92/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Dizziness	14.8% 87/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Muscular weakness	14.3% 84/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Back pain	14.1% 83/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Skin and subcutaneous tissue disorders Rash	13.8% 81/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Cough	12.8% 75/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Lethargy	12.6% 74/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Headache	11.4% 67/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Lower respiratory tract infection	11.4% 67/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Nasopharyngitis	10.9% 64/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Dysgeusia	10.7% 63/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Pyrexia	9.9% 58/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 56/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Eye disorders Vision blurred	9.4% 55/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Mood altered	9.0% 53/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
General disorders Asthenia	8.9% 52/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Anorexia	8.2% 48/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hyperglycaemia	8.2% 48/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Vomiting	8.0% 47/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Neuropathy peripheral	7.8% 46/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Paraesthesia	7.8% 46/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.3% 43/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Pain in extremity	7.3% 43/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Dyspepsia	7.0% 41/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Psychiatric disorders Confusional state	6.8% 40/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.8% 40/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	6.6% 39/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Metabolism and nutrition disorders Hypocalcaemia	6.0% 35/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Neuropathy	6.0% 35/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.6% 33/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 33/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Nervous system disorders Peripheral sensory neuropathy	5.6% 33/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Investigations Weight decreased	5.6% 33/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Respiratory tract infection	5.5% 32/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Dry mouth	5.8% 34/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Infections and infestations Urinary tract infection	5.5% 32/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Gastrointestinal disorders Mouth ulceration	5.3% 31/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Shoulder pain	5.3% 31/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
Musculoskeletal and connective tissue disorders Bone pain	5.1% 30/587 • Up to 123 weeks A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.

Additional Information

Associate Director, Clinical Trials Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: clinicaltrialdisclosure@celgene.com

Results disclosure agreements

• Principal investigator is a sponsor employee * Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. It has priority over subset (single center) publication, for duration of 1 year after study completion. * Individual investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 180 days.
• Publication restrictions are in place

Restriction type: OTHER