Trial Outcomes & Findings for Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide (NCT NCT01432600)

Last Updated: 2017-05-23

Results Overview

The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity related to treatment with pomalidomide or cyclophosphamide; Participants must have received optimal symptomatic treatment for Grade 3 or 4 nausea, vomiting, or diarrhea to be considered a DLT; Grade 4 transaminitis; Grade 3 transaminitis must be present for ≥ 7 days to be considered a DLT; Grade 4 thrombocytopenia for 7 or more days; Grade 4 neutropenia for 7 or more days.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

80 participants

Primary outcome timeframe

28 Days

Results posted on

2017-05-23

Participant Flow

Between December 2011 and March 2014, participants were enrolled at: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.

Participant milestones

Participant milestones
Measure	A: Dose Escalation of Cyclophosphamide Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	B: Pomalidomide and Dexamethasone Phase II: Pomalidomide and high dose dexamethasone. Arm D participants may be referenced separately in some Outcome Measures.	C: Pomalidomide, Dexamethasone, Cyclophosphamide Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
Overall Study STARTED	10	36	34
Overall Study COMPLETED	10	35	33
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	A: Dose Escalation of Cyclophosphamide Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	B: Pomalidomide and Dexamethasone Phase II: Pomalidomide and high dose dexamethasone. Arm D participants may be referenced separately in some Outcome Measures.	C: Pomalidomide, Dexamethasone, Cyclophosphamide Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
Overall Study Rapid PD, allocated intv. not rec'd	0	1	1

Baseline Characteristics

Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A: Dose Escalation of Cyclophosphamide n=10 Participants Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	B: Pomalidomide and Dexamethasone n=36 Participants Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.	C: Pomalidomide, Dexamethasone, Cyclophosphamide n=34 Participants Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	39 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	41 Participants n=4 Participants
Age, Continuous	69 years n=5 Participants	64 years n=7 Participants	62 years n=5 Participants	63 years n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	23 Participants n=7 Participants	18 Participants n=5 Participants	48 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	36 participants n=7 Participants	34 participants n=5 Participants	80 participants n=4 Participants

PRIMARY outcome

Timeframe: 28 Days

Population: All Phase I Participants.

Outcome measures

Outcome measures
Measure	A: Dose Escalation of Cyclophosphamide n=10 Participants Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	C: Pomalidomide, Dexamethasone, Cyclophosphamide Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	D: Crossover Arm Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Phase I - Maximum Tolerated Dose (MTD)	400 mg	—	—

PRIMARY outcome

Timeframe: 36 Months

Population: All Phase II Participants.

Overall response, Minimal Remission (MR) or better per treatment arm, using the uniform response criteria by the International Myeloma Working Group (IMWG) of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in participants with relapsed and refractory myeloma. In addition, Minimal response was incorporated in those response criteria as this is a valid endpoint in patients with relapsed or refractory myeloma. MR: 25-49% reduction in serum paraprotein and a 50-89% reduction in urine light chain excretion; A 25-49% reduction in the size of soft tissue plasmacytoma must be demonstrated is applicable.

Outcome measures

Outcome measures
Measure	A: Dose Escalation of Cyclophosphamide n=36 Participants Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	C: Pomalidomide, Dexamethasone, Cyclophosphamide n=34 Participants Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	D: Crossover Arm Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Phase II - Overall Response Rate (ORR)	38.9 percentage of participants Interval 23.0 to 54.8	64.7 percentage of participants Interval 48.6 to 80.8	—

SECONDARY outcome

Timeframe: 36 Months

Population: All Phase II Participants.

Progression free survival per treatment arm. Progressive Disease (PD) requires one of the following, increase of greater than or equal to 25% from baseline in: Serum M-component; Urine M-component; The difference between involved and uninvolved sFLC levels; The size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia.

Outcome measures

Outcome measures
Measure	A: Dose Escalation of Cyclophosphamide n=36 Participants Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	C: Pomalidomide, Dexamethasone, Cyclophosphamide n=34 Participants Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	D: Crossover Arm Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Phase II - Median Progression Free Survival (PFS)	4.4 months Interval 2.3 to 5.7	9.5 months Interval 4.6 to 14.0	—

SECONDARY outcome

Timeframe: 36 Months

Population: All participants assigned to Arm B and Arm C.

Overall survival per treatment arm. Overall survival is defined as the time from start of treatment to death of any cause.

Outcome measures

Outcome measures
Measure	A: Dose Escalation of Cyclophosphamide n=36 Participants Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	C: Pomalidomide, Dexamethasone, Cyclophosphamide n=34 Participants Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	D: Crossover Arm Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Phase II - Median Overall Survival (OS)	16.8 months Interval 9.3 to not reached	NA months Interval 13.1 to not reached	—

SECONDARY outcome

Timeframe: Up to 48 Months

Population: All Phase II Participants who completed allocated intervention.

Phase II: Participants with Grade 3 or 4 adverse events at least possibly related to the study treatment in 5% of participants in the Phase 2 portion, by AE category, assessed by the National Cancer Institute Common Terminology Criteria (NCI CTC) version 4.0.

Outcome measures

Outcome measures
Measure	A: Dose Escalation of Cyclophosphamide n=35 Participants Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	C: Pomalidomide, Dexamethasone, Cyclophosphamide n=33 Participants Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	D: Crossover Arm n=17 Participants Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Anemia	11.4 percentage of participants	24.2 percentage of participants	5.9 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Febrile neutropenia	11.4 percentage of participants	12.1 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Fatigue	8.6 percentage of participants	1.21 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Flu-like symptoms	0 percentage of participants	0 percentage of participants	5.9 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Lung infection	11.4 percentage of participants	9.1 percentage of participants	5.9 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Sepsis	0 percentage of participants	9.1 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Upper respiratory infection	0 percentage of participants	6.1 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Lymphodemia	11.4 percentage of participants	9.1 percentage of participants	11.8 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Neutropenia	31.4 percentage of participants	51.5 percentage of participants	23.5 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Thrombocytopenia	5.7 percentage of participants	15.2 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Leukopenia	14.3 percentage of participants	12.1 percentage of participants	5.9 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Hyperglycemia	0 percentage of participants	6.1 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Hyponatremia	0 percentage of participants	6.1 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Hypophosphatemia	0 percentage of participants	0 percentage of participants	5.9 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Hypoxia	0 percentage of participants	0 percentage of participants	5.9 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Confusion	0 percentage of participants	6.1 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Pneumonitis	0 percentage of participants	9.1 percentage of participants	0 percentage of participants
Phase II - Occurrence of Possibly Related Adverse Events (AEs) Thromboembolic event	0 percentage of participants	6.1 percentage of participants	0 percentage of participants

Adverse Events

A: Dose Escalation of Cyclophosphamide

Serious events: 10 serious events

Other events: 10 other events

Deaths: 0 deaths

B: Pomalidomide and Dexamethasone

Serious events: 11 serious events

Other events: 35 other events

Deaths: 0 deaths

C: Pomalidomide, Dexamethasone, Cyclophosphamide

Serious events: 19 serious events

Other events: 33 other events

Deaths: 0 deaths

D: Crossover Arm

Serious events: 9 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Rachid Baz

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-8212

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	A: Dose Escalation of Cyclophosphamide n=10 participants at risk Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	B: Pomalidomide and Dexamethasone n=36 participants at risk Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.	C: Pomalidomide, Dexamethasone, Cyclophosphamide n=34 participants at risk Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	D: Crossover Arm n=17 participants at risk Phase II: Participants who crossed over from Arm B to Arm D.
Blood and lymphatic system disorders Anemia	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.8% 3/34 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Blood and lymphatic system disorders Febrile Neutropenia	30.0% 3/10 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 4/34 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 2/17 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Cardiac disorders Atrial fibrillation	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Cardiac disorders Cardiac disorders - Other	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Eye disorders Retinal vascular disorder	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Colitis	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Colonic hemorrhage	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Colonic obstruction	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Colonic perforation	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Gastrointestinal disorders, Other	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Rectal hemorrhage	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Fatigue	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Fever	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders General disorders - Other	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 2/17 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Non-cardiac chest pain	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Pain	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Appendicitis	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Infections and infestations - Other	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 4/34 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Lung infection	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.1% 4/36 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.8% 3/34 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	17.6% 3/17 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Sepsis	20.0% 2/10 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Sinusitis	10.0% 1/10 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Upper respiratory infection	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 2/34 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Injury, poisoning and procedural complications Fracture	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Creatinine increased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Platelet count decreased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders - Other	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Nervous system disorders Dizziness	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Nervous system disorders Neuralgia	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Nervous system disorders Stroke	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Renal and urinary disorders Renal and urinary disorders - Other	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 2/17 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).

Other adverse events
Measure	A: Dose Escalation of Cyclophosphamide n=10 participants at risk Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.	B: Pomalidomide and Dexamethasone n=36 participants at risk Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.	C: Pomalidomide, Dexamethasone, Cyclophosphamide n=34 participants at risk Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.	D: Crossover Arm n=17 participants at risk Phase II: Participants who crossed over from Arm B to Arm D.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 4/34 • Number of events 6 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.8% 3/34 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Gastrointestinal disorders Mucositis oral	20.0% 2/10 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Blood and lymphatic system disorders Anemia	20.0% 2/10 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	41.7% 15/36 • Number of events 21 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	50.0% 17/34 • Number of events 54 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	35.3% 6/17 • Number of events 10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Blood and lymphatic system disorders Febrile Neutropenia	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 2/34 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Blood and lymphatic system disorders Blood and Lymphatic System Disorders - Other	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Blood and lymphatic system disorders Spleen disorder	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Neutrophil count decreased	60.0% 6/10 • Number of events 10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	44.4% 16/36 • Number of events 36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	58.8% 20/34 • Number of events 76 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	47.1% 8/17 • Number of events 18 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Platelet count decreased	80.0% 8/10 • Number of events 10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	27.8% 10/36 • Number of events 15 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	47.1% 16/34 • Number of events 46 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 2/17 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations White blood cell decreased	20.0% 2/10 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	19.4% 7/36 • Number of events 13 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	23.5% 8/34 • Number of events 52 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	23.5% 4/17 • Number of events 15 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Lymphocyte count decreased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.1% 4/36 • Number of events 20 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 4/34 • Number of events 24 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	17.6% 3/17 • Number of events 15 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Weight gain	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.3% 3/36 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 4/34 • Number of events 5 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Aspartate aminotransferase increased	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.3% 3/36 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 2/34 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Alanine aminotransferase increased	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Alkaline phosphatase increased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 2/17 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Weight loss	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.8% 3/34 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Creatinine increased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Blood bilirubin increased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Carbon monoxide diffusing capacity decreased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Cardiac troponin I increased	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Investigations Cardiac troponin T increased	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Fatigue	20.0% 2/10 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	33.3% 12/36 • Number of events 12 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	20.6% 7/34 • Number of events 9 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 2/17 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Pain	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.3% 3/36 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	29.4% 10/34 • Number of events 14 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Fever	30.0% 3/10 • Number of events 5 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	16.7% 6/36 • Number of events 6 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 4/34 • Number of events 8 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Edema limbs	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.1% 4/36 • Number of events 5 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	17.6% 6/34 • Number of events 7 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	20.6% 7/34 • Number of events 12 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	11.8% 2/17 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Chills	20.0% 2/10 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.3% 3/36 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.9% 1/34 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Flu like symptoms	20.0% 2/10 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 2/34 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Non-cardiac chest pain	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Gait disturbance	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Irritability	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/36 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 2/34 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Edema trunk	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Localized edema	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
General disorders Malaise	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/34 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Lung infection	10.0% 1/10 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.3% 3/36 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	14.7% 5/34 • Number of events 7 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	17.6% 3/17 • Number of events 3 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Infections and infestations - Other, specify	0.00% 0/10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	13.9% 5/36 • Number of events 6 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.8% 3/34 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Upper respiratory infection	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	13.9% 5/36 • Number of events 8 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	14.7% 5/34 • Number of events 10 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.9% 1/17 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Sepsis	40.0% 4/10 • Number of events 5 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	2.8% 1/36 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	14.7% 5/34 • Number of events 5 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).
Infections and infestations Skin infection	10.0% 1/10 • Number of events 1 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	5.6% 2/36 • Number of events 2 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	8.8% 3/34 • Number of events 4 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).	0.00% 0/17 • 4 years, 1 month All participants assigned to Arms A, B, C, plus Arm D group of participants formerly in Arm B (Arm B occurrences listed under B, Arm D occurrences listed under D).