Trial Outcomes & Findings for Pomalidomide for the Treatment of Bleeding in HHT (NCT NCT03910244)

NCT ID: NCT03910244

Last Updated: 2024-10-23

Results Overview

The primary outcome measure is the change from baseline in Epistaxis Severity Score (ESS) after 6 months of treatment administration to compare the outcomes of Pomalidomide versus Placebo. The ESS ranges from 0-10 with higher scores indicating worse condition in the prior 4 weeks. The minimal important difference is 0.71

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

4, 8, 12, 16, 20, and 24 Weeks and 4 weeks post treatment

Results posted on

2024-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Pomalidomide Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks	Placebo Daily dose of placebo for 24 weeks
Overall Study STARTED	95	49
Overall Study COMPLETED	63	41
Overall Study NOT COMPLETED	32	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Pomalidomide Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks	Placebo Daily dose of placebo for 24 weeks
Overall Study Adverse Event	14	0
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	2
Overall Study Joint withdrawal decision	1	0
Overall Study Study Terminated by Sponsor	7	4
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	7	2

Baseline Characteristics

Pomalidomide for the Treatment of Bleeding in HHT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=95 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks	Total n=144 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 11 • n=5 Participants	58.8 years STANDARD_DEVIATION 13 • n=7 Participants	58.8 years STANDARD_DEVIATION 12 • n=5 Participants
Sex/Gender, Customized Female	24 Participants n=5 Participants	45 Participants n=7 Participants	69 Participants n=5 Participants
Sex/Gender, Customized Male	25 Participants n=5 Participants	50 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White	41 Participants n=5 Participants	85 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	44 Participants n=5 Participants	90 Participants n=7 Participants	134 Participants n=5 Participants
Race/Ethnicity, Customized Unknown/Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Marital status Divorced	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Marital status Domestic Partner	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Marital status Married	33 Participants n=5 Participants	64 Participants n=7 Participants	97 Participants n=5 Participants
Marital status Never Been Married	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Marital status Separated	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Marital status Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Marital status Widowed	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Pre-menopausal No	17 Participants n=5 Participants	33 Participants n=7 Participants	50 Participants n=5 Participants
Pre-menopausal Not Applicable	25 Participants n=5 Participants	50 Participants n=7 Participants	75 Participants n=5 Participants
Pre-menopausal Yes	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Education Associate degree	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Education Bachelor�s degree	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Education Doctoral degree	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Education Don�t Know	18 Participants n=5 Participants	36 Participants n=7 Participants	54 Participants n=5 Participants
Education High School Grad	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Education Master�s degree	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Education Refused	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Education Years of college no degree (specify)	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Education grade (specify)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Employment status Disabled permanently or temporary	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Employment status Looking for work unemployed	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Employment status Other (specify)	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Employment status Retired	12 Participants n=5 Participants	28 Participants n=7 Participants	40 Participants n=5 Participants
Employment status Working Now	25 Participants n=5 Participants	48 Participants n=7 Participants	73 Participants n=5 Participants
Emergency room for epistaxis in the previous 3 months No	40 Participants n=5 Participants	79 Participants n=7 Participants	119 Participants n=5 Participants
Emergency room for epistaxis in the previous 3 months Yes	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
History of or current GI bleeding No	30 Participants n=5 Participants	61 Participants n=7 Participants	91 Participants n=5 Participants
History of or current GI bleeding Yes	19 Participants n=5 Participants	34 Participants n=7 Participants	53 Participants n=5 Participants
HHT involvement of the brain No	39 Participants n=5 Participants	77 Participants n=7 Participants	116 Participants n=5 Participants
HHT involvement of the brain Unknown	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
HHT involvement of the brain Yes	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
HHT involvement of the liver No	28 Participants n=5 Participants	47 Participants n=7 Participants	75 Participants n=5 Participants
HHT involvement of the liver Unknown	11 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants
HHT involvement of the liver Yes	10 Participants n=5 Participants	25 Participants n=7 Participants	35 Participants n=5 Participants
HHT involvement of the lungs No	25 Participants n=5 Participants	45 Participants n=7 Participants	70 Participants n=5 Participants
HHT involvement of the lungs Unknown	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
HHT involvement of the lungs Yes	16 Participants n=5 Participants	42 Participants n=7 Participants	58 Participants n=5 Participants
HHT Diagnosis Genetically Confirmed No	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
HHT Diagnosis Genetically Confirmed Yes	46 Participants n=5 Participants	88 Participants n=7 Participants	134 Participants n=5 Participants
Endoglin Gene (ENG) Mutation Known Pathogenic Mutation	13 Participants n=5 Participants	35 Participants n=7 Participants	48 Participants n=5 Participants
Endoglin Gene (ENG) Mutation No Mutation	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants
Endoglin Gene (ENG) Mutation Not done	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Endoglin Gene (ENG) Mutation Unknown	23 Participants n=5 Participants	33 Participants n=7 Participants	56 Participants n=5 Participants
Endoglin Gene (ENG) Mutation Variant of Unknown Significanc	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Endoglin Gene (ENG) Mutation Variant, Likely Pathogenic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Activin A Receptor Like Type 1 Gene (ACVRL1) Mutation Known Pathogenic Mutation	25 Participants n=5 Participants	34 Participants n=7 Participants	59 Participants n=5 Participants
Activin A Receptor Like Type 1 Gene (ACVRL1) Mutation No Mutation	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Activin A Receptor Like Type 1 Gene (ACVRL1) Mutation Not done	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Activin A Receptor Like Type 1 Gene (ACVRL1) Mutation Unknown	8 Participants n=5 Participants	30 Participants n=7 Participants	38 Participants n=5 Participants
Activin A Receptor Like Type 1 Gene (ACVRL1) Mutation Variant of Unknown Significanc	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Activin A Receptor Like Type 1 Gene (ACVRL1) Mutation Variant, Likely Pathogenic	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
SMAD4 Mutation Known Pathogenic Mutation	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
SMAD4 Mutation No Mutation	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
SMAD4 Mutation Not done	6 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants
SMAD4 Mutation Unknown	33 Participants n=5 Participants	61 Participants n=7 Participants	94 Participants n=5 Participants
EPHB4 Mutation No Mutation	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
EPHB4 Mutation Not done	6 Participants n=5 Participants	21 Participants n=7 Participants	27 Participants n=5 Participants
EPHB4 Mutation Unknown	33 Participants n=5 Participants	62 Participants n=7 Participants	95 Participants n=5 Participants
Growth Differentiation Factor 2 (GDF2) Mutation No Mutation	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Growth Differentiation Factor 2 (GDF2) Mutation Not done	6 Participants n=5 Participants	17 Participants n=7 Participants	23 Participants n=5 Participants
Growth Differentiation Factor 2 (GDF2) Mutation Unknown	33 Participants n=5 Participants	62 Participants n=7 Participants	95 Participants n=5 Participants
RAS p21 Protein Activator (RASA1) Mutation No Mutation	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
RAS p21 Protein Activator (RASA1) Mutation Not done	6 Participants n=5 Participants	17 Participants n=7 Participants	23 Participants n=5 Participants
RAS p21 Protein Activator (RASA1) Mutation Unknown	33 Participants n=5 Participants	61 Participants n=7 Participants	94 Participants n=5 Participants
RAS p21 Protein Activator (RASA1) Mutation Variant of Unknown Significanc	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4, 8, 12, 16, 20, and 24 Weeks and 4 weeks post treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The primary outcome measure is the change from baseline in Epistaxis Severity Score (ESS) after 6 months of treatment administration to compare the outcomes of Pomalidomide versus Placebo. The ESS ranges from 0-10 with higher scores indicating worse condition in the prior 4 weeks. The minimal important difference is 0.71

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Change From Baseline Epistaxis Severity Score 4 Weeks	-1 units on a scale Interval -1.4 to -0.6	-1.1 units on a scale Interval -1.5 to -0.7
Change From Baseline Epistaxis Severity Score 8 Weeks	-1.3 units on a scale Interval -1.8 to -0.7	-1.2 units on a scale Interval -1.6 to -0.8
Change From Baseline Epistaxis Severity Score 12 Weeks	-1.3 units on a scale Interval -1.9 to -0.8	-1.6 units on a scale Interval -2.0 to -1.2
Change From Baseline Epistaxis Severity Score 16 Weeks	-1.2 units on a scale Interval -1.9 to -0.6	-2 units on a scale Interval -2.4 to -1.6
Change From Baseline Epistaxis Severity Score 20 Weeks	-1.3 units on a scale Interval -1.9 to -0.6	-2 units on a scale Interval -2.4 to -1.5
Change From Baseline Epistaxis Severity Score 24 Weeks	-1.2 units on a scale Interval -1.9 to -0.5	-2.1 units on a scale Interval -2.6 to -1.5
Change From Baseline Epistaxis Severity Score 4 Weeks Post-treatmenr	-0.7 units on a scale Interval -1.3 to 0.0	-1.6 units on a scale Interval -2.1 to -1.2

SECONDARY outcome

Timeframe: After 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The daily epistaxis duration is calculated as the total duration of all reported nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=73 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Average Total Daily Duration of Nosebleeds - Change From Baseline 12 Weeks	-4 minutes Interval -8.4 to 0.5	-6.7 minutes Interval -10.4 to -3.0
Average Total Daily Duration of Nosebleeds - Change From Baseline 24 Weeks	-4.4 minutes Interval -10.5 to 1.7	-5.3 minutes Interval -11.0 to 0.5
Average Total Daily Duration of Nosebleeds - Change From Baseline 4 Weeks Post-treatment	-1.7 minutes Interval -7.5 to 4.2	-4.6 minutes Interval -7.9 to -1.3

SECONDARY outcome

Timeframe: After 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The daily epistaxis duration is calculated as the total duration of all reported nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary, weighted by the intensity, with 90%% winsorization. The outcome is the change between the baseline diary on the specified timepoint

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=73 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Weighted Average Total Daily Duration of Nosebleeds - Change From Baseline 12 Weeks	-4.3 minutes Interval -10.4 to 1.7	-12.1 minutes Interval -16.6 to -7.6
Weighted Average Total Daily Duration of Nosebleeds - Change From Baseline 24 Weeks	-4 minutes Interval -13.5 to 5.6	-11.5 minutes Interval -16.6 to -6.3
Weighted Average Total Daily Duration of Nosebleeds - Change From Baseline 4 Weeks Post-treatment	-2.6 minutes Interval -10.6 to 5.4	-9.3 minutes Interval -14.1 to -4.6

SECONDARY outcome

Timeframe: Baseline through 24 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Total iron infused (mg) is calculated as the total in 4 weeks, averaged across all visits reported through the 24-week treatment period. Patients with no infusions have a value of zero.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Total Iron Infused	204 mg/4 weeks Interval 33.0 to 341.0	170 mg/4 weeks Interval 0.0 to 408.0

SECONDARY outcome

Timeframe: Baseline through 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Total iron infused (mg) is calculated as the total in 4 weeks, averaged across all visits reported through the first 12 weeks of the treatment period. Patients with no infusions have a value of zero.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Total Iron Infused	170 mg/4 weeks Interval 0.0 to 340.0	225 mg/4 weeks Interval 0.0 to 510.0

SECONDARY outcome

Timeframe: 12 through 24 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Total iron infused (mg) is calculated as the total in 4 weeks, averaged across all visits reported through the second 12 weeks of the treatment period. Patients with no infusions have a value of zero.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=74 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Total Iron Infused	333.3 mg/4 weeks Interval 0.0 to 500.0	0 mg/4 weeks Interval 0.0 to 340.0

SECONDARY outcome

Timeframe: Baseline through 24 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Patients with any packed red blood cells transfusion through the 24-week treatment period

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Patients With Any Packed Red Blood Cells Transfusion Through 24 Weeks No transfusion	38 Participants	77 Participants
Patients With Any Packed Red Blood Cells Transfusion Through 24 Weeks Yes transfusion	11 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline through 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Patients with any packed red blood cells transfusion through the first 12 weeks of the treatment period

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Patients With Any Packed Red Blood Cells Transfusion Through 12 Weeks No transfusion	43 Participants	79 Participants
Patients With Any Packed Red Blood Cells Transfusion Through 12 Weeks Yes transfusion	6 Participants	13 Participants

SECONDARY outcome

Timeframe: 12 through 24 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Patients with any packed red blood cells transfusion through the second 12 weeks of the treatment period

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=74 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Patients With Any Packed Red Blood Cells Transfusion 12-24 Weeks No transfusion	37 Participants	67 Participants
Patients With Any Packed Red Blood Cells Transfusion 12-24 Weeks Yes transfusion	8 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The outcome measure is the Neuro-QoL Satisfaction with Social Roles and Activities T-Score to compare the outcomes of Pomalidomide versus Placebo. The Neuro-QoL Satisfaction with Social Roles and Activities Short Form (V1.1) T-score has a value of 50 representing the average general US population, with a standard deviation of 10, and with higher scores indicating more satisfaction. The minimal detectable change is 3.7 T score points

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Neuro-QoL - Satisfaction With Social Roles and Activities - T Score 4 Weeks Post-treatment	45.6 units on a scale Interval 43.0 to 48.3	48.8 units on a scale Interval 47.2 to 50.4
Neuro-QoL - Satisfaction With Social Roles and Activities - T Score Baseline	44.7 units on a scale Interval 42.9 to 46.4	45.5 units on a scale Interval 44.1 to 46.8
Neuro-QoL - Satisfaction With Social Roles and Activities - T Score 12 Weeks	46.5 units on a scale Interval 44.6 to 48.4	47.5 units on a scale Interval 46.1 to 49.0
Neuro-QoL - Satisfaction With Social Roles and Activities - T Score 24 Weeks	46 units on a scale Interval 43.7 to 48.2	47.6 units on a scale Interval 46.0 to 49.3

SECONDARY outcome

Timeframe: Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The outcome measure is the PROMIS Emotional Distress - Depression T-Score to compare the outcomes of Pomalidomide versus Placebo. The PROMIS Emotional Distress-Depression Short Form (V1.0) T-score has a value of 50 representing the average general US population, with a standard deviation of 10, and with higher scores indicating more depression

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) - Emotional Distress - Depression - T Score Baseline	0.2 units on a scale Interval 0.0 to 0.5	-0.1 units on a scale Interval -0.3 to 0.1
Patient Reported Outcomes Measurement Information System (PROMIS) - Emotional Distress - Depression - T Score 12 Weeks	0 units on a scale Interval -0.3 to 0.3	-0.1 units on a scale Interval -0.3 to 0.1
Patient Reported Outcomes Measurement Information System (PROMIS) - Emotional Distress - Depression - T Score 24 Weeks	-0.1 units on a scale Interval -0.4 to 0.2	-0.2 units on a scale Interval -0.4 to 0.1
Patient Reported Outcomes Measurement Information System (PROMIS) - Emotional Distress - Depression - T Score 4 Weeks Post-treatment	0.1 units on a scale Interval -0.3 to 0.5	-0.3 units on a scale Interval -0.5 to -0.1

SECONDARY outcome

Timeframe: Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The outcome measure is the PROMIS Fatigue T-Score to compare the outcomes of Pomalidomide versus Placebo. The PROMIS® Fatigue Short Form (V1.0) T-score has a value of 50 representing the average general US population, with a standard deviation of 10, and with higher scores indicating more fatigue

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
PROMIS - Fatigue - T Score Baseline	57.7 units on a scale Interval 54.6 to 60.8	55.7 units on a scale Interval 53.6 to 57.8
PROMIS - Fatigue - T Score 12 Weeks	55.8 units on a scale Interval 53.2 to 58.3	54.7 units on a scale Interval 52.5 to 56.9
PROMIS - Fatigue - T Score 24 Weeks	56.2 units on a scale Interval 52.9 to 59.6	54.2 units on a scale Interval 51.6 to 56.9
PROMIS - Fatigue - T Score 4 Weeks Post-treatment	59.5 units on a scale Interval 56.0 to 63.1	52.3 units on a scale Interval 50.1 to 54.5

SECONDARY outcome

Timeframe: Baseline, after 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The outcome measure is the HHT-Specific QOL Questionnaire - Score to compare the outcomes of Pomalidomide versus Placebo. The HHT-specific QOL score ranges from 0 to 16 with higher scores indicating more limitations due to HHT in the prior 4 weeks

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=91 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
HHT-Specific QOL Questionnaire - Score Baseline	7.1 units on a scale Interval 6.1 to 8.1	5.8 units on a scale Interval 5.2 to 6.4
HHT-Specific QOL Questionnaire - Score 12 Weeks	5 units on a scale Interval 3.9 to 6.1	3.5 units on a scale Interval 2.7 to 4.3
HHT-Specific QOL Questionnaire - Score 24 Weeks	5.6 units on a scale Interval 4.4 to 6.8	3.6 units on a scale Interval 2.8 to 4.3
HHT-Specific QOL Questionnaire - Score 4 Weeks Post-treatment	5.9 units on a scale Interval 4.5 to 7.4	3.7 units on a scale Interval 2.9 to 4.4

OTHER_PRE_SPECIFIED outcome

Timeframe: After 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The daily of low intensity epistaxis duration is calculated as the total duration of "spotting" or "dripping" nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=73 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Average Total Daily Duration of Low Intensity Nosebleeds - Change From Baseline 12 Weeks	-2 minutes Interval -5.2 to 1.3	-1.6 minutes Interval -2.9 to -0.2
Average Total Daily Duration of Low Intensity Nosebleeds - Change From Baseline 24 Weeks	-2.8 minutes Interval -6.1 to 0.5	-1.6 minutes Interval -2.7 to -0.4
Average Total Daily Duration of Low Intensity Nosebleeds - Change From Baseline 4 Weeks Post-treatment	-1.8 minutes Interval -5.0 to 1.3	-0.6 minutes Interval -2.0 to 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: After 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The daily of medium intensity epistaxis duration is calculated as the total duration of "dripping quickly" or "steady stream" nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=73 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Average Total Daily Duration of Medium Intensity Nosebleeds - Change From Baseline 12 Weeks	-1.9 minutes Interval -4.1 to 0.4	-3.6 minutes Interval -6.0 to -1.3
Average Total Daily Duration of Medium Intensity Nosebleeds - Change From Baseline 24 Weeks	-3.6 minutes Interval -8.7 to 1.6	-2.2 minutes Interval -7.0 to 2.7
Average Total Daily Duration of Medium Intensity Nosebleeds - Change From Baseline 4 Weeks Post-treatment	-2 minutes Interval -6.3 to 2.4	-2.5 minutes Interval -4.9 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: After 12 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

The daily of high intensity epistaxis duration is calculated as the total duration of "gushing" or "pouring" nose bleeding events in a day, averaged across all days reported in a 4-week smartphone diary. The outcome is the change between the baseline diary on the specified timepoint

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=73 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Average Total Daily Duration of High Intensity Nosebleeds - Change From Baseline 12 Weeks	-0.1 minutes Interval -1.5 to 1.2	-1.4 minutes Interval -2.6 to -0.2
Average Total Daily Duration of High Intensity Nosebleeds - Change From Baseline 24 Weeks	1.9 minutes Interval -2.7 to 6.5	-1.5 minutes Interval -2.8 to -0.1
Average Total Daily Duration of High Intensity Nosebleeds - Change From Baseline 4 Weeks Post-treatment	2 minutes Interval -3.9 to 7.9	-1.6 minutes Interval -3.3 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 24 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Total blood transfused (units of blood) is calculated as the total in 4 weeks, averaged across all visits reported through the 24-week treatment period. Patients with no transfusions have a value of zero.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Total Blood Transfused	0 units of blood/4 weeks Interval 0.0 to 0.0	0 units of blood/4 weeks Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Total blood transfused (units of blood) is calculated as the total in 4 weeks, averaged across all visits reported through the first 12 weeks of the treatment period. Patients with no transfusions have a value of zero.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Total Blood Transfused	0 units of blood/4 weeks Interval 0.0 to 0.0	0 units of blood/4 weeks Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 through 24 Weeks

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Total blood transfused (units of blood) is calculated as the total in 4 weeks, averaged across all visits reported through the second 12 weeks of the treatment period. Patients with no transfusions have a value of zero.

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=74 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Total Blood Transfused	0 units of blood/4 weeks Interval 0.0 to 0.0	0 units of blood/4 weeks Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Change from baseline transferrin saturation collected from blood iron studies

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=87 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Transferrin Saturation 4 Weeks	8.2 Percent Interval -7.2 to 23.6	-3.7 Percent Interval -8.7 to 1.2
Transferrin Saturation 8 Weeks	4.4 Percent Interval -4.1 to 12.8	-1.1 Percent Interval -6.6 to 4.4
Transferrin Saturation 12 Weeks	-2.3 Percent Interval -7.9 to 3.4	9 Percent Interval -2.5 to 20.6
Transferrin Saturation 16 Weeks	3.8 Percent Interval -4.7 to 12.3	3.3 Percent Interval -2.6 to 9.2
Transferrin Saturation 20 Weeks	6.2 Percent Interval -5.3 to 17.8	1.5 Percent Interval -3.8 to 6.8
Transferrin Saturation 24 Weeks	10.1 Percent Interval -0.3 to 20.4	22.7 Percent Interval -17.5 to 62.9
Transferrin Saturation 4 Weeks Post-treatment	12.8 Percent Interval -9.4 to 35.1	1.2 Percent Interval -4.2 to 6.5

OTHER_PRE_SPECIFIED outcome

Timeframe: After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Change from baseline ferritin level collected from blood iron studies

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=92 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Ferritin 4 Weeks	-25.5 ng/mL Interval -48.5 to -2.6	-6.5 ng/mL Interval -42.3 to 29.4
Ferritin 8 Weeks	11.5 ng/mL Interval -28.4 to 51.3	2.6 ng/mL Interval -45.4 to 50.6
Ferritin 12 Weeks	-12.4 ng/mL Interval -48.1 to 23.3	2.5 ng/mL Interval -32.2 to 37.1
Ferritin 16 Weeks	13.1 ng/mL Interval -35.4 to 61.5	8.2 ng/mL Interval -32.1 to 48.4
Ferritin 20 Weeks	31.6 ng/mL Interval -24.7 to 87.9	-7.4 ng/mL Interval -46.3 to 31.5
Ferritin 24 Weeks	47.4 ng/mL Interval -12.3 to 107.1	-5.4 ng/mL Interval -41.0 to 30.2
Ferritin 4 Weeks Post-treatment	-10.9 ng/mL Interval -49.3 to 27.4	-18.5 ng/mL Interval -59.8 to 22.9

OTHER_PRE_SPECIFIED outcome

Timeframe: After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Change from baseline Hemoglobin level taken from complete blood counts

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=91 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Hemoglobin 20 Weeks	0 g/dL Interval -0.6 to 0.7	0.4 g/dL Interval -0.2 to 0.9
Hemoglobin 24 Weeks	-0.1 g/dL Interval -0.6 to 0.5	0.3 g/dL Interval -0.2 to 0.9
Hemoglobin 4 Weeks Post-treatment	-0.5 g/dL Interval -1.2 to 0.2	0.7 g/dL Interval 0.1 to 1.2
Hemoglobin 4 Weeks	-0.2 g/dL Interval -0.5 to 0.2	-0.4 g/dL Interval -0.7 to -0.1
Hemoglobin 8 Weeks	-0.3 g/dL Interval -0.7 to 0.1	-0.3 g/dL Interval -0.6 to 0.1
Hemoglobin 12 Weeks	0 g/dL Interval -0.6 to 0.6	0 g/dL Interval -0.4 to 0.4
Hemoglobin 16 Weeks	-0.2 g/dL Interval -0.9 to 0.4	0.4 g/dL Interval -0.1 to 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Change from baseline Hematocrit level taken from complete blood counts

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=91 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Hematocrit 4 Weeks	-0.3 Percent Interval -1.4 to 0.8	-1.4 Percent Interval -2.3 to -0.4
Hematocrit 24 Weeks	-0.7 Percent Interval -2.3 to 0.9	0.3 Percent Interval -1.3 to 1.9
Hematocrit 8 Weeks	-0.7 Percent Interval -1.9 to 0.5	-0.9 Percent Interval -2.1 to 0.3
Hematocrit 12 Weeks	0.1 Percent Interval -1.4 to 1.6	-0.2 Percent Interval -1.5 to 1.1
Hematocrit 16 Weeks	-0.6 Percent Interval -2.4 to 1.2	0.4 Percent Interval -1.0 to 1.7
Hematocrit 20 Weeks	-0.3 Percent Interval -2.0 to 1.4	0.2 Percent Interval -1.3 to 1.7
Hematocrit 4 Weeks Post-treatment	-1.6 Percent Interval -3.5 to 0.3	1 Percent Interval -0.4 to 2.4

OTHER_PRE_SPECIFIED outcome

Timeframe: After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Change from baseline MCV level taken from complete blood counts

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=91 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Mean Corpuscular Volume (MCV) 4 Weeks	-0.1 fL Interval -1.1 to 0.8	-0.4 fL Interval -1.3 to 0.4
Mean Corpuscular Volume (MCV) 8 Weeks	0 fL Interval -1.1 to 1.1	-1.2 fL Interval -2.3 to -0.2
Mean Corpuscular Volume (MCV) 12 Weeks	0.1 fL Interval -1.3 to 1.4	0.1 fL Interval -1.0 to 1.2
Mean Corpuscular Volume (MCV) 16 Weeks	-0.2 fL Interval -2.0 to 1.6	0.9 fL Interval -0.4 to 2.1
Mean Corpuscular Volume (MCV) 20 Weeks	1.3 fL Interval -0.6 to 3.2	2.2 fL Interval 0.7 to 3.6
Mean Corpuscular Volume (MCV) 24 Weeks	1.6 fL Interval -0.5 to 3.7	3.2 fL Interval 1.6 to 4.8
Mean Corpuscular Volume (MCV) 4 Weeks Post-treatment	0.2 fL Interval -1.8 to 2.3	3.2 fL Interval 1.6 to 4.7

OTHER_PRE_SPECIFIED outcome

Timeframe: After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Change from baseline MCHC level taken from complete blood counts

Outcome measures

Outcome measures
Measure	Placebo n=47 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=91 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Mean Corpuscular Hemoglobin Concentration (MCHC) 4 Weeks	-0.2 g/dL Interval -0.5 to 0.1	0 g/dL Interval -0.3 to 0.3
Mean Corpuscular Hemoglobin Concentration (MCHC) 8 Weeks	-0.2 g/dL Interval -0.5 to 0.1	0.1 g/dL Interval -0.2 to 0.4
Mean Corpuscular Hemoglobin Concentration (MCHC) 12 Weeks	0 g/dL Interval -0.5 to 0.4	0.1 g/dL Interval -0.2 to 0.4
Mean Corpuscular Hemoglobin Concentration (MCHC) 16 Weeks	-0.2 g/dL Interval -0.7 to 0.3	0.6 g/dL Interval 0.3 to 1.0
Mean Corpuscular Hemoglobin Concentration (MCHC) 20 Weeks	0.3 g/dL Interval -0.3 to 0.9	0.7 g/dL Interval 0.3 to 1.2
Mean Corpuscular Hemoglobin Concentration (MCHC) 24 Weeks	0 g/dL Interval -0.4 to 0.4	0.6 g/dL Interval 0.2 to 1.1
Mean Corpuscular Hemoglobin Concentration (MCHC) 4 Weeks Post-treatment	-0.2 g/dL Interval -0.7 to 0.3	0.9 g/dL Interval 0.3 to 1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: After 4, 8, 12, 16, 20 and 24 weeks of treatment, and 4 weeks post-treatment

Population: An intent-to-treat (ITT) analysis which included all randomized participants who provided outcome data.

Change from baseline platelets taken from complete blood counts

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Daily dose of placebo for 24 weeks	Pomalidomide n=91 Participants Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Platelets 20 Weeks	-2.1 10^3/uL platelets Interval -18.1 to 13.9	-24.1 10^3/uL platelets Interval -46.1 to -2.1
Platelets 4 Weeks	7.8 10^3/uL platelets Interval -5.7 to 21.3	13.4 10^3/uL platelets Interval -8.0 to 34.9
Platelets 8 Weeks	-2.3 10^3/uL platelets Interval -17.4 to 12.7	19.3 10^3/uL platelets Interval -0.6 to 39.2
Platelets 12 Weeks	4.9 10^3/uL platelets Interval -12.9 to 22.7	0.9 10^3/uL platelets Interval -18.2 to 20.1
Platelets 16 Weeks	10.3 10^3/uL platelets Interval -15.9 to 36.5	-19.7 10^3/uL platelets Interval -36.9 to -2.5
Platelets 24 Weeks	4 10^3/uL platelets Interval -11.5 to 19.5	-27.3 10^3/uL platelets Interval -51.5 to -3.0
Platelets 4 Weeks Post-treatment	5.7 10^3/uL platelets Interval -11.6 to 22.9	-13 10^3/uL platelets Interval -33.0 to 7.0

Adverse Events

Placebo

Serious events: 8 serious events

Other events: 43 other events

Deaths: 0 deaths

Pomalidomide

Serious events: 22 serious events

Other events: 90 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=49 participants at risk Daily dose of placebo for 24 weeks	Pomalidomide n=95 participants at risk Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Blood and lymphatic system disorders Anaemia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Haemorrhagic anaemia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Neutropenia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Aortic valve stenosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Atrial fibrillation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiac failure	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiac failure congestive	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Ventricular tachycardia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Colitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastrointestinal haemorrhage	4.1% 2/49 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Haematochezia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Hepatobiliary disorders Portal vein thrombosis	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Corona virus infection	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Extradural abscess	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Herpes simplex	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Liver abscess	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Pilonidal cyst	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Pneumonia	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Sepsis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Septic shock	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Haemoglobin decreased	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Fluid overload	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Syncope	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Transient ischaemic attack	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Surgical and medical procedures Cardiac ablation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Deep vein thrombosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.

Other adverse events

Other adverse events
Measure	Placebo n=49 participants at risk Daily dose of placebo for 24 weeks	Pomalidomide n=95 participants at risk Daily dose of 4, 3, or 2 mg of Pomalidomide for 24 weeks
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Anaemia	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Increased tendency to bruise	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Iron deficiency anaemia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	5.3% 5/95 • Number of events 5 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Leukocytosis	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Leukopenia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	9.5% 9/95 • Number of events 15 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Lymphadenopathy	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Lymphopenia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Neutropenia	10.2% 5/49 • Number of events 9 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	43.2% 41/95 • Number of events 70 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 6 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Bradycardia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiac failure	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiac failure congestive	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiac failure high output	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiac hypertrophy	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiac valve disease	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Cardiomegaly	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Mitral valve incompetence	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Palpitations	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Pericardial effusion	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Sinus tachycardia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Tachycardia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Cardiac disorders Tricuspid valve incompetence	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Congenital, familial and genetic disorders Hepatic arteriovenous malformation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Congenital, familial and genetic disorders Ichthyosis	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Ear and labyrinth disorders Ear pain	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Ear and labyrinth disorders Otorrhoea	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Ear and labyrinth disorders Tinnitus	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Endocrine disorders Hypothyroidism	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Blepharitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Corneal scar	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Dry eye	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Eye irritation	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Eye pruritus	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Ulcerative keratitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Vision blurred	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Eye disorders Visual impairment	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Abdominal discomfort	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Abdominal distension	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	8.4% 8/95 • Number of events 8 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Abdominal pain	6.1% 3/49 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Colitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Constipation	18.4% 9/49 • Number of events 9 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	47.4% 45/95 • Number of events 51 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Dental caries	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Diarrhoea	14.3% 7/49 • Number of events 7 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	7.4% 7/95 • Number of events 8 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Diverticulum	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Dry mouth	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	9.5% 9/95 • Number of events 9 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Dyspepsia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Dysphagia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Faeces discoloured	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Flatulence	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Food poisoning	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastric polyps	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastritis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastrointestinal angiectasia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastrointestinal angiodysplasia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Glossodynia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Haematochezia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Haemorrhoidal haemorrhage	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Lip dry	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Melaena	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Mouth ulceration	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Nausea	16.3% 8/49 • Number of events 8 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	15.8% 15/95 • Number of events 16 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Oesophagitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Oral dysaesthesia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Retching	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Small intestinal haemorrhage	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Splenic artery aneurysm	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Tongue eruption	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Toothache	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Gastrointestinal disorders Vomiting	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Asthenia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Chest discomfort	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Chest pain	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Chills	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Discomfort	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Face oedema	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Fatigue	34.7% 17/49 • Number of events 20 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	44.2% 42/95 • Number of events 48 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Feeling abnormal	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Feeling jittery	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Generalised oedema	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Influenza like illness	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Localised oedema	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Loss of control of legs	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Mucosal dryness	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Non-cardiac chest pain	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Oedema	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	5.3% 5/95 • Number of events 5 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Oedema peripheral	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	14.7% 14/95 • Number of events 14 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Pain	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Pyrexia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Sensation of foreign body	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
General disorders Thirst	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Hepatobiliary disorders Cholelithiasis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Hepatobiliary disorders Hepatic lesion	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Immune system disorders Multiple allergies	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Immune system disorders Seasonal allergy	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Bacteraemia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Bronchitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Bursitis infective	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Carbuncle	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Cellulitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Conjunctivitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Corona virus infection	18.4% 9/49 • Number of events 9 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	9.5% 9/95 • Number of events 9 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Eye infection	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Fungal infection	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Hordeolum	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Infective glossitis	2.0% 1/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Influenza	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Lip infection	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Nasopharyngitis	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Oral herpes	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Pneumonia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Sinusitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Tonsillitis	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Tooth abscess	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Upper respiratory tract infection	4.1% 2/49 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Urinary tract infection	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	5.3% 5/95 • Number of events 6 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Infections and infestations Viral pharyngitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Contusion	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Fall	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Laceration	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Procedural pain	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Tendon rupture	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Injury, poisoning and procedural complications Vaccination complication	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Alanine aminotransferase increased	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Aspartate aminotransferase increased	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Blood alkaline phosphatase increased	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Cardiac murmur	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Heart rate increased	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations International normalised ratio increased	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Right ventricular systolic pressure increased	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Investigations Weight increased	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Decreased appetite	4.1% 2/49 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Dehydration	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Fluid overload	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Fluid retention	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Gout	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Hyperglycaemia	2.0% 1/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Hypophosphataemia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Increased appetite	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Malnutrition	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	6.3% 6/95 • Number of events 7 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	5.3% 5/95 • Number of events 5 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Joint swelling	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Muscle spasms	12.2% 6/49 • Number of events 7 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	13.7% 13/95 • Number of events 14 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Muscular weakness	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Myalgia	6.1% 3/49 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Pain in extremity	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Focal nodular hyperplasia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Anosmia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Disturbance in attention	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Dizziness	14.3% 7/49 • Number of events 8 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	16.8% 16/95 • Number of events 17 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Dysgeusia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Headache	6.1% 3/49 • Number of events 5 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	13.7% 13/95 • Number of events 14 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Hepatic encephalopathy	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Hypoaesthesia	6.1% 3/49 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Hypogeusia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Memory impairment	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Mental impairment	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Migraine	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Neuralgia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Neuropathy peripheral	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Paraesthesia	4.1% 2/49 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Presyncope	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Sciatica	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Somnolence	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Syncope	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Nervous system disorders Tremor	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	8.4% 8/95 • Number of events 8 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Psychiatric disorders Anxiety	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Psychiatric disorders Confusional state	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Psychiatric disorders Insomnia	10.2% 5/49 • Number of events 5 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Renal and urinary disorders Acute kidney injury	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Renal and urinary disorders Chronic kidney disease	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Renal and urinary disorders Haematuria	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Renal and urinary disorders Pollakiuria	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Renal and urinary disorders Renal cyst	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Reproductive system and breast disorders Breast tenderness	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Cough	6.1% 3/49 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.2% 5/49 • Number of events 5 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	23.2% 22/95 • Number of events 24 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	5.3% 5/95 • Number of events 5 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Actinic keratosis	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Alopecia	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	6.3% 6/95 • Number of events 6 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Erythema	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	13.7% 13/95 • Number of events 14 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Rash	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	21.1% 20/95 • Number of events 20 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Rash erythematous	4.1% 2/49 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	4.2% 4/95 • Number of events 4 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	5.3% 5/95 • Number of events 6 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Skin warm	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Skin and subcutaneous tissue disorders Urticaria	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	6.3% 6/95 • Number of events 7 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Surgical and medical procedures Cataract operation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Surgical and medical procedures Gastrointestinal endoscopic therapy	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Surgical and medical procedures Sinus operation	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Surgical and medical procedures Tooth extraction	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Surgical and medical procedures Transurethral bladder resection	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Angiopathy	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Deep vein thrombosis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Fibromuscular dysplasia	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Flushing	2.0% 1/49 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	0.00% 0/95 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Haematoma	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Hot flush	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	3.2% 3/95 • Number of events 3 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Hypotension	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	2.1% 2/95 • Number of events 2 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Orthostatic hypotension	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Pallor	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Peripheral artery aneurysm	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Thrombophlebitis	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.
Vascular disorders Varicose vein ruptured	0.00% 0/49 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.	1.1% 1/95 • Number of events 1 • 6 Months Patients were randomized to 2 groups: placebo and pomalidomide. All patients in the pomalidomide group were started on 4 mg and dose could be reduced (to 3 mg or 2 mg) or temporarily stopped by the investigator due to side effects. So a single participant could have administrations of each of the 4 mg, 3 mg, and 2 mg doses during the course of the study. Since participants were not necessarily unique to a dose level, adverse events are presented by treatment and not by treatment and dose.

Additional Information

Keith McCrae, MD

Cleveland Clinic

Phone: 216-445-7809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60