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Clinical Trial Results:
An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma

Summary
EudraCT number	2015-005699-21
Trial protocol	CZ AT SE DK NO ES PT DE GR PL IT
Global end of trial date	09 Mar 2022

Results information
Results version number	v1(current)
This version publication date	16 Mar 2023
First version publication date	16 Mar 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CA209-602

ISRCTN number

US NCT number

NCT02726581

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussée de la Hulpe 185, Brussels, Belgium, 1170

Public contact

EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

11 Apr 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

09 Mar 2022

Was the trial ended prematurely?

Main objective of the trial

The primary objective is to compare progression free survival (PFS) between N-Pd and Pd arms, by investigator.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Aug 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 3

Country: Number of subjects enrolled

Canada: 11

Country: Number of subjects enrolled

Czechia: 31

Country: Number of subjects enrolled

Denmark: 8

Country: Number of subjects enrolled

Germany: 2

Country: Number of subjects enrolled

Israel: 21

Country: Number of subjects enrolled

Italy: 12

Country: Number of subjects enrolled

Norway: 3

Country: Number of subjects enrolled

Portugal: 8

Country: Number of subjects enrolled

Puerto Rico: 1

Country: Number of subjects enrolled

Spain: 11

Country: Number of subjects enrolled

Sweden: 3

Country: Number of subjects enrolled

Switzerland: 1

Country: Number of subjects enrolled

United States: 55

Worldwide total number of subjects

170

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

This study contains an exploratory third arm evaluating the clinical benefit and the safety of the combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone (Arm C: NE-Pd). Participants randomized to the Pd arm were allowed to cross over to this exploratory NE-Pd arm at the time of progression.

Period 1 title

Pre-Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Arm A: N-Pd

Arm description

Nivolumab: - Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle - Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle Dexamethasone: - Subjects </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle - Subjects > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Arm type

Experimental

Investigational medicinal product name

Pomalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 mg PO QD

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection, Solution for infusion, Tablet

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Participants </= 75years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle, Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

480 mg IV

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

240 mg IV

Arm B: Pd

Arm description

Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle Dexamethasone: - Subjects </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle - Subjects > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Arm type

Experimental

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection, Solution for infusion, Tablet

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Participants </= 75years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle, Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Investigational medicinal product name

Pomalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 mg PO QD

Arm C: NE-Pd

Arm description

Nivolumab: - Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle - Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle Elotuzumab: - Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle - Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle - Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle Dexamethasone: Days 1, 8, 15, and 22 of each cycle - Subjects </= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks - Subjects > 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

240 mg IV

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

480 mg IV

Investigational medicinal product name

Elotuzumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

20 mg/kg IV

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection, Solution for infusion, Tablet

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Participants </= 75years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle, Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Investigational medicinal product name

Elotuzumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg IV

Investigational medicinal product name

Pomalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 mg PO QD

Number of subjects in period 1	Arm A: N-Pd	Arm B: Pd	Arm C: NE-Pd
Started	75	71	24
Completed	72	70	24
Not completed	3	1	0
Participant no longer meets study criteria	1	-	-
Administrative reason by sponsor	2	-	-
Participant request to discontinue study treatment	-	1	-

Period 2 title

Treatment Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Arm A: N-Pd

Arm description

Arm type

Experimental

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection, Solution for infusion, Tablet

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Participants </= 75years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle, Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

240 mg IV

Investigational medicinal product name

Pomalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 mg PO QD

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

480 mg IV

Arm B: Pd

Arm description

Arm type

Experimental

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection, Solution for infusion, Tablet

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Participants </= 75years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle, Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Investigational medicinal product name

Pomalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 mg PO QD

Arm C: NE-Pd

Arm description

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

240 mg IV

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection, Solution for infusion, Tablet

Routes of administration

Intravenous use, Oral use

Dosage and administration details

Participants </= 75years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle, Participants > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle

Investigational medicinal product name

Elotuzumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg IV

Investigational medicinal product name

Elotuzumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

20 mg/kg IV

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

480 mg IV

Investigational medicinal product name

Pomalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 mg PO QD

Number of subjects in period 2	Arm A: N-Pd	Arm B: Pd	Arm C: NE-Pd
Started	72	70	24
NE-Pd Crossover	0	8	0
Completed	0	0	0
Not completed	72	70	24
Adverse event, serious fatal	1	-	-
Disease progression	47	50	16
Participant withdrew consent	3	1	1
Study drug toxicity	6	3	2
Maximum clinical benefit	-	2	-
Participant no longer meets study criteria	-	1	-
Adverse event unrelated to study drug	4	4	2
Other reasons	9	8	2
Poor/non-compliance	1	-	-
Participant request to discontinue study treatment	1	1	1

Baseline characteristics

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Reporting group title

Arm A: N-Pd

Reporting group description

Reporting group title

Arm B: Pd

Reporting group description

Reporting group title

Arm C: NE-Pd

Reporting group description

Reporting group values	Arm A: N-Pd	Arm B: Pd	Arm C: NE-Pd	Total
Number of subjects	75	71	24	170
Age categorical
Units: Subjects
Adults (18-64 years)	32	29	10	71
From 65-84 years	43	42	14	99
85 years and over	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	65.9 ± 9.4	65.5 ± 8.7	66.2 ± 11.5	-
Sex: Female, Male
Units: Participants
Female	24	25	8	57
Male	51	46	16	113
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	3	5	5	13
White	72	64	19	155
More than one race	0	0	0	0
Unknown or Not Reported	0	2	0	2
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	4	1	6
Not Hispanic or Latino	40	41	15	96
Unknown or Not Reported	34	26	8	68

End points

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Reporting group title

Arm A: N-Pd

Reporting group description

Reporting group title

Arm B: Pd

Reporting group description

Reporting group title

Arm C: NE-Pd

Reporting group description

Reporting group title

Arm A: N-Pd

Reporting group description

Reporting group title

Arm B: Pd

Reporting group description

Reporting group title

Arm C: NE-Pd

Reporting group description

Primary: Progression Free Survival (PFS)

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End point title

Progression Free Survival (PFS) ^[1]

End point description

Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), >/= 50% increase from nadir in SPD of > 1 lesion, or >/= 50% increase in the longest diameter of a previous lesion > 1 cm in short axis.

End point type

Primary

End point timeframe

From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This study contains an exploratory third arm not included in endpoint analysis.

End point values	Arm A: N-Pd	Arm B: Pd
Number of subjects analysed	75	71
Units: Months
median (confidence interval 95%)	8.38 (5.78 to 12.06)	7.33 (6.47 to 8.44)

Summary of Progression-Free Survival

Comparison groups

Arm A: N-Pd v Arm B: Pd

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

Method

Parameter type

Hazard ratio (HR)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.62

upper limit

1.3

Secondary: Objective Response Rate (ORR)

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End point title

Objective Response Rate (ORR) ^[2]

End point description

The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria. sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h. PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.

End point type

Secondary

End point timeframe

From randomization up to approximately 64 months

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This study contains an exploratory third arm not included in endpoint analysis.

End point values	Arm A: N-Pd	Arm B: Pd
Number of subjects analysed	75	71
Units: Percentage of participants
number (confidence interval 95%)	48.0 (36.3 to 59.8)	54.9 (42.7 to 66.8)

Summary Objective Response Rate

Comparison groups

Arm A: N-Pd v Arm B: Pd

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

Method

Parameter type

Odds ratio (OR)

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

0.39

upper limit

1.46

Secondary: Overall Survival (OS)

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End point title

Overall Survival (OS) ^[3]

End point description

The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.

End point type

Secondary

End point timeframe

From randomization to the date of death due to any cause (up to approximately 64 months)

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This study contains an exploratory third arm not included in endpoint analysis.

End point values	Arm A: N-Pd	Arm B: Pd
Number of subjects analysed	75	71
Units: Months
median (confidence interval 95%)	24.87 (15.61 to 34.40)	21.39 (17.91 to 27.56)

Summary of Overall Survival

Comparison groups

Arm A: N-Pd v Arm B: Pd

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

Method

Parameter type

Hazard ratio (HR)

Point estimate

0.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.53

upper limit

1.19

Secondary: Duration of Objective Response (DOR)

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End point title

Duration of Objective Response (DOR) ^[4]

End point description

The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), >/= 50% increase from nadir in SPD of > 1 lesion, or >/= 50% increase in the longest diameter of a previous lesion > 1 cm in short axis.

End point type

Secondary

End point timeframe

From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This study contains an exploratory third arm not included in endpoint analysis.

End point values	Arm A: N-Pd	Arm B: Pd
Number of subjects analysed	36	39
Units: Months
median (confidence interval 95%)	8.51 (6.47 to 13.83)	6.47 (5.55 to 11.07)

No statistical analyses for this end point

Secondary: Time to Objective Response (TTR)

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End point title

Time to Objective Response (TTR) ^[5]

End point description

The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h. PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.

End point type

Secondary

End point timeframe

From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This study contains an exploratory third arm not included in endpoint analysis.

End point values	Arm A: N-Pd	Arm B: Pd
Number of subjects analysed	36	39
Units: Months
arithmetic mean (standard deviation)	5.91 ± 9.09	4.37 ± 5.63

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AEs/NSAEs assessed from first dose to 100 days post last dose (up to approximately 63 months) Participants were assessed for all-cause mortality from their randomization to the study's Primary completion (up to approximately 64 months).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Arm A: N-Pd

Reporting group description

Nivolumab: - Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. - Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: - Subjects </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle - Subjects > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

Reporting group title

Arm B: NE-Pd Crossover

Reporting group description

Participants who progressed on the Pd control arm and were allowed to crossover to the NE-Pd exploratory arm.

Reporting group title

Arm C: NE-Pd

Reporting group description

Nivolumab: - Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. - Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Elotuzumab: - Cycles 1 - 2: 10 mg/kg IV Days 1, 8, 15, and 22 of each 28-day cycle. - Cycle 3 and 4: 10mg/kg IV Day 1 and 15 of each 28-day cycle. - Cycles 5 and beyond: 20 mg/kg IV Day 1 of each 28-day cycle. Pomalidomide: 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: Days 1, 8, 15, and 22 of each cycle. - Subjects </= 75 years old: weeks with elotuzumab dosing: 28 mg PO + 8 mg IV and 40 mg PO on non-elotuzumab dosing weeks. - Subjects > 75 years old: weeks with elotuzumab dosing: 8 mg PO + 8 mg IV and 20 mg PO on non-elotuzumab dosing weeks.

Reporting group title

Arm B: Pd

Reporting group description

Pomalidomide: - 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: - Subjects </= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle - Subjects > 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.

Serious adverse events	Arm A: N-Pd	Arm B: NE-Pd Crossover	Arm C: NE-Pd	Arm B: Pd
Total subjects affected by serious adverse events
subjects affected / exposed	52 / 72 (72.22%)	5 / 8 (62.50%)	18 / 24 (75.00%)	41 / 70 (58.57%)
number of deaths (all causes)	47	5	17	49
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal neoplasm
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Lung cancer metastatic
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Malignant neoplasm progression
subjects affected / exposed	9 / 72 (12.50%)	2 / 8 (25.00%)	4 / 24 (16.67%)	6 / 70 (8.57%)
occurrences causally related to treatment / all	0 / 9	0 / 2	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 8	0 / 2	0 / 4	0 / 6
Plasma cell leukaemia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 72 (1.39%)	1 / 8 (12.50%)	2 / 24 (8.33%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 2	0 / 1
Plasmacytoma
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rectal neoplasm
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Refractory cytopenia with unilineage dysplasia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Circulatory collapse
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Haematoma
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Embolism
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Condition aggravated
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza like illness
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Localised oedema
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	5 / 72 (6.94%)	0 / 8 (0.00%)	1 / 24 (4.17%)	4 / 70 (5.71%)
occurrences causally related to treatment / all	3 / 5	0 / 0	1 / 1	4 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sudden death
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
Immune system disorders
Hypogammaglobulinaemia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	1 / 72 (1.39%)	1 / 8 (12.50%)	0 / 24 (0.00%)	3 / 70 (4.29%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	2 / 72 (2.78%)	1 / 8 (12.50%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	2 / 2	1 / 1	3 / 3	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	2 / 72 (2.78%)	1 / 8 (12.50%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 2	1 / 1	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Confusional state
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Platelet count decreased
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin laceration
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Overdose
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrioventricular block complete
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Cardiac arrest
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Encephalopathy
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Cerebral thrombosis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Facial nerve disorder
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lacunar stroke
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	2 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tremor
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	1 / 24 (4.17%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	1 / 3	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	1 / 24 (4.17%)	3 / 70 (4.29%)
occurrences causally related to treatment / all	1 / 3	0 / 0	0 / 1	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	5 / 5	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	1 / 24 (4.17%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Renal failure
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	1 / 24 (4.17%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Acute kidney injury
subjects affected / exposed	5 / 72 (6.94%)	0 / 8 (0.00%)	4 / 24 (16.67%)	3 / 70 (4.29%)
occurrences causally related to treatment / all	0 / 5	0 / 0	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Osteonecrosis of jaw
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchitis
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	1 / 24 (4.17%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	3 / 24 (12.50%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cytomegalovirus viraemia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Herpes simplex
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumocystis jirovecii infection
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	9 / 72 (12.50%)	0 / 8 (0.00%)	6 / 24 (25.00%)	17 / 70 (24.29%)
occurrences causally related to treatment / all	4 / 10	0 / 0	2 / 6	8 / 20
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Pneumonia cytomegaloviral
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia parainfluenzae viral
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumococcal sepsis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Pneumonia fungal
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus bronchiolitis
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	0 / 24 (0.00%)	3 / 70 (4.29%)
occurrences causally related to treatment / all	1 / 3	0 / 0	0 / 0	2 / 3
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Rhinovirus infection
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Sepsis
subjects affected / exposed	8 / 72 (11.11%)	1 / 8 (12.50%)	3 / 24 (12.50%)	3 / 70 (4.29%)
occurrences causally related to treatment / all	2 / 8	1 / 1	2 / 3	0 / 3
deaths causally related to treatment / all	1 / 5	0 / 0	0 / 1	0 / 0
Septic shock
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Staphylococcal bacteraemia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular device infection
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypoglycaemia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fluid retention
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	2 / 70 (2.86%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dehydration
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Arm A: N-Pd	Arm B: NE-Pd Crossover	Arm C: NE-Pd	Arm B: Pd
Total subjects affected by non serious adverse events
subjects affected / exposed	70 / 72 (97.22%)	7 / 8 (87.50%)	24 / 24 (100.00%)	65 / 70 (92.86%)
Vascular disorders
Hypertension
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	2 / 24 (8.33%)	9 / 70 (12.86%)
occurrences all number	5	0	2	9
Haematoma
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	2 / 24 (8.33%)	0 / 70 (0.00%)
occurrences all number	0	0	2	0
Embolism
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Aortic stenosis
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Hypotension
subjects affected / exposed	3 / 72 (4.17%)	1 / 8 (12.50%)	3 / 24 (12.50%)	1 / 70 (1.43%)
occurrences all number	3	1	4	2
General disorders and administration site conditions
Fatigue
subjects affected / exposed	34 / 72 (47.22%)	6 / 8 (75.00%)	10 / 24 (41.67%)	24 / 70 (34.29%)
occurrences all number	44	6	11	28
Chills
subjects affected / exposed	2 / 72 (2.78%)	1 / 8 (12.50%)	0 / 24 (0.00%)	4 / 70 (5.71%)
occurrences all number	5	1	0	5
Chest pain
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	0 / 24 (0.00%)	4 / 70 (5.71%)
occurrences all number	3	0	0	4
Asthenia
subjects affected / exposed	15 / 72 (20.83%)	2 / 8 (25.00%)	4 / 24 (16.67%)	12 / 70 (17.14%)
occurrences all number	18	2	4	12
Non-cardiac chest pain
subjects affected / exposed	5 / 72 (6.94%)	0 / 8 (0.00%)	0 / 24 (0.00%)	4 / 70 (5.71%)
occurrences all number	5	0	0	4
Pyrexia
subjects affected / exposed	10 / 72 (13.89%)	1 / 8 (12.50%)	14 / 24 (58.33%)	9 / 70 (12.86%)
occurrences all number	16	3	28	21
Pain
subjects affected / exposed	1 / 72 (1.39%)	1 / 8 (12.50%)	1 / 24 (4.17%)	6 / 70 (8.57%)
occurrences all number	1	1	1	6
Oedema peripheral
subjects affected / exposed	14 / 72 (19.44%)	1 / 8 (12.50%)	7 / 24 (29.17%)	15 / 70 (21.43%)
occurrences all number	17	1	7	17
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	2 / 24 (8.33%)	0 / 70 (0.00%)
occurrences all number	0	0	2	0
Respiratory, thoracic and mediastinal disorders
Atelectasis
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences all number	0	1	0	1
Wheezing
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	4 / 70 (5.71%)
occurrences all number	1	0	0	5
Pulmonary embolism
subjects affected / exposed	1 / 72 (1.39%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	1	1	0	0
Productive cough
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	1 / 24 (4.17%)	2 / 70 (2.86%)
occurrences all number	4	0	1	2
Pneumonitis
subjects affected / exposed	1 / 72 (1.39%)	1 / 8 (12.50%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences all number	1	1	4	0
Cough
subjects affected / exposed	11 / 72 (15.28%)	0 / 8 (0.00%)	6 / 24 (25.00%)	12 / 70 (17.14%)
occurrences all number	20	0	8	15
Dysphonia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	1 / 24 (4.17%)	4 / 70 (5.71%)
occurrences all number	1	0	1	4
Dyspnoea
subjects affected / exposed	13 / 72 (18.06%)	2 / 8 (25.00%)	6 / 24 (25.00%)	15 / 70 (21.43%)
occurrences all number	19	2	8	20
Epistaxis
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	3 / 24 (12.50%)	3 / 70 (4.29%)
occurrences all number	4	0	3	3
Hypoxia
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	2 / 24 (8.33%)	1 / 70 (1.43%)
occurrences all number	3	0	2	1
Nasal congestion
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	0 / 24 (0.00%)	4 / 70 (5.71%)
occurrences all number	1	0	0	5
Psychiatric disorders
Insomnia
subjects affected / exposed	11 / 72 (15.28%)	0 / 8 (0.00%)	1 / 24 (4.17%)	11 / 70 (15.71%)
occurrences all number	11	0	1	11
Anxiety
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	2 / 24 (8.33%)	4 / 70 (5.71%)
occurrences all number	2	0	2	6
Confusional state
subjects affected / exposed	5 / 72 (6.94%)	1 / 8 (12.50%)	2 / 24 (8.33%)	6 / 70 (8.57%)
occurrences all number	6	1	3	7
Hallucination
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Investigations
White blood cell count decreased
subjects affected / exposed	6 / 72 (8.33%)	0 / 8 (0.00%)	2 / 24 (8.33%)	7 / 70 (10.00%)
occurrences all number	13	0	4	17
Weight decreased
subjects affected / exposed	4 / 72 (5.56%)	2 / 8 (25.00%)	3 / 24 (12.50%)	0 / 70 (0.00%)
occurrences all number	5	2	6	0
Platelet count decreased
subjects affected / exposed	5 / 72 (6.94%)	1 / 8 (12.50%)	4 / 24 (16.67%)	7 / 70 (10.00%)
occurrences all number	8	1	4	9
Neutrophil count decreased
subjects affected / exposed	7 / 72 (9.72%)	0 / 8 (0.00%)	3 / 24 (12.50%)	6 / 70 (8.57%)
occurrences all number	16	0	10	19
Lymphocyte count decreased
subjects affected / exposed	7 / 72 (9.72%)	0 / 8 (0.00%)	1 / 24 (4.17%)	6 / 70 (8.57%)
occurrences all number	14	0	3	10
Blood creatinine increased
subjects affected / exposed	8 / 72 (11.11%)	0 / 8 (0.00%)	3 / 24 (12.50%)	4 / 70 (5.71%)
occurrences all number	13	0	3	6
Aspartate aminotransferase increased
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	2 / 24 (8.33%)	2 / 70 (2.86%)
occurrences all number	1	0	2	5
Alanine aminotransferase increased
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	2 / 24 (8.33%)	2 / 70 (2.86%)
occurrences all number	2	0	2	7
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	3 / 72 (4.17%)	1 / 8 (12.50%)	4 / 24 (16.67%)	3 / 70 (4.29%)
occurrences all number	3	2	4	4
Cardiac disorders
Sinus bradycardia
subjects affected / exposed	1 / 72 (1.39%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences all number	1	1	0	1
Nervous system disorders
Dizziness
subjects affected / exposed	8 / 72 (11.11%)	0 / 8 (0.00%)	7 / 24 (29.17%)	10 / 70 (14.29%)
occurrences all number	8	0	11	15
Headache
subjects affected / exposed	7 / 72 (9.72%)	1 / 8 (12.50%)	3 / 24 (12.50%)	7 / 70 (10.00%)
occurrences all number	10	1	3	7
Hypoaesthesia
subjects affected / exposed	3 / 72 (4.17%)	1 / 8 (12.50%)	1 / 24 (4.17%)	2 / 70 (2.86%)
occurrences all number	3	1	1	2
Neuropathy peripheral
subjects affected / exposed	2 / 72 (2.78%)	1 / 8 (12.50%)	2 / 24 (8.33%)	6 / 70 (8.57%)
occurrences all number	2	1	2	7
Paraesthesia
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	0 / 24 (0.00%)	4 / 70 (5.71%)
occurrences all number	3	0	0	4
Peripheral sensory neuropathy
subjects affected / exposed	5 / 72 (6.94%)	0 / 8 (0.00%)	1 / 24 (4.17%)	1 / 70 (1.43%)
occurrences all number	5	0	1	1
Tremor
subjects affected / exposed	8 / 72 (11.11%)	0 / 8 (0.00%)	2 / 24 (8.33%)	6 / 70 (8.57%)
occurrences all number	8	0	2	6
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	4 / 72 (5.56%)	1 / 8 (12.50%)	2 / 24 (8.33%)	2 / 70 (2.86%)
occurrences all number	4	2	3	2
Lymphopenia
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	1 / 24 (4.17%)	1 / 70 (1.43%)
occurrences all number	0	1	2	1
Neutropenia
subjects affected / exposed	24 / 72 (33.33%)	0 / 8 (0.00%)	10 / 24 (41.67%)	22 / 70 (31.43%)
occurrences all number	68	0	16	46
Thrombocytopenia
subjects affected / exposed	16 / 72 (22.22%)	0 / 8 (0.00%)	4 / 24 (16.67%)	11 / 70 (15.71%)
occurrences all number	30	0	5	17
Pancytopenia
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences all number	0	1	0	1
Anaemia
subjects affected / exposed	26 / 72 (36.11%)	2 / 8 (25.00%)	11 / 24 (45.83%)	20 / 70 (28.57%)
occurrences all number	38	2	14	25
Eye disorders
Vitreous detachment
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Cataract
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	0 / 24 (0.00%)	4 / 70 (5.71%)
occurrences all number	4	0	0	4
Vision blurred
subjects affected / exposed	10 / 72 (13.89%)	1 / 8 (12.50%)	1 / 24 (4.17%)	2 / 70 (2.86%)
occurrences all number	11	1	1	2
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	1 / 24 (4.17%)	5 / 70 (7.14%)
occurrences all number	2	0	1	5
Abdominal pain
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	0 / 24 (0.00%)	5 / 70 (7.14%)
occurrences all number	3	0	0	7
Abdominal pain upper
subjects affected / exposed	5 / 72 (6.94%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences all number	6	0	1	0
Constipation
subjects affected / exposed	17 / 72 (23.61%)	0 / 8 (0.00%)	4 / 24 (16.67%)	15 / 70 (21.43%)
occurrences all number	20	0	4	20
Diarrhoea
subjects affected / exposed	22 / 72 (30.56%)	2 / 8 (25.00%)	5 / 24 (20.83%)	17 / 70 (24.29%)
occurrences all number	29	2	6	21
Dry mouth
subjects affected / exposed	3 / 72 (4.17%)	1 / 8 (12.50%)	1 / 24 (4.17%)	5 / 70 (7.14%)
occurrences all number	3	1	1	5
Dyspepsia
subjects affected / exposed	5 / 72 (6.94%)	0 / 8 (0.00%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences all number	5	0	1	0
Dysphagia
subjects affected / exposed	2 / 72 (2.78%)	1 / 8 (12.50%)	1 / 24 (4.17%)	0 / 70 (0.00%)
occurrences all number	2	1	1	0
Nausea
subjects affected / exposed	14 / 72 (19.44%)	2 / 8 (25.00%)	4 / 24 (16.67%)	11 / 70 (15.71%)
occurrences all number	15	2	4	17
Vomiting
subjects affected / exposed	5 / 72 (6.94%)	1 / 8 (12.50%)	2 / 24 (8.33%)	6 / 70 (8.57%)
occurrences all number	7	2	2	8
Skin and subcutaneous tissue disorders
Erythema
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	2 / 24 (8.33%)	0 / 70 (0.00%)
occurrences all number	4	0	2	0
Alopecia
subjects affected / exposed	1 / 72 (1.39%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences all number	1	1	0	1
Rash
subjects affected / exposed	11 / 72 (15.28%)	1 / 8 (12.50%)	3 / 24 (12.50%)	8 / 70 (11.43%)
occurrences all number	13	1	4	9
Pruritus
subjects affected / exposed	9 / 72 (12.50%)	0 / 8 (0.00%)	2 / 24 (8.33%)	4 / 70 (5.71%)
occurrences all number	10	0	2	4
Renal and urinary disorders
Urinary retention
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences all number	0	1	0	1
Urinary incontinence
subjects affected / exposed	0 / 72 (0.00%)	0 / 8 (0.00%)	2 / 24 (8.33%)	0 / 70 (0.00%)
occurrences all number	0	0	2	0
Chronic kidney disease
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	2 / 24 (8.33%)	4 / 70 (5.71%)
occurrences all number	1	0	2	4
Endocrine disorders
Hypothyroidism
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	2 / 24 (8.33%)	0 / 70 (0.00%)
occurrences all number	4	0	2	0
Hyperthyroidism
subjects affected / exposed	2 / 72 (2.78%)	0 / 8 (0.00%)	2 / 24 (8.33%)	1 / 70 (1.43%)
occurrences all number	2	0	2	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	11 / 72 (15.28%)	1 / 8 (12.50%)	0 / 24 (0.00%)	8 / 70 (11.43%)
occurrences all number	11	1	0	9
Back pain
subjects affected / exposed	12 / 72 (16.67%)	1 / 8 (12.50%)	4 / 24 (16.67%)	15 / 70 (21.43%)
occurrences all number	15	1	4	18
Bone pain
subjects affected / exposed	7 / 72 (9.72%)	1 / 8 (12.50%)	0 / 24 (0.00%)	6 / 70 (8.57%)
occurrences all number	8	1	0	6
Muscle spasms
subjects affected / exposed	6 / 72 (8.33%)	1 / 8 (12.50%)	3 / 24 (12.50%)	11 / 70 (15.71%)
occurrences all number	6	1	3	15
Muscular weakness
subjects affected / exposed	6 / 72 (8.33%)	0 / 8 (0.00%)	5 / 24 (20.83%)	4 / 70 (5.71%)
occurrences all number	6	0	5	4
Neck pain
subjects affected / exposed	3 / 72 (4.17%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences all number	4	1	0	1
Musculoskeletal chest pain
subjects affected / exposed	6 / 72 (8.33%)	1 / 8 (12.50%)	2 / 24 (8.33%)	4 / 70 (5.71%)
occurrences all number	6	1	2	5
Pain in extremity
subjects affected / exposed	7 / 72 (9.72%)	1 / 8 (12.50%)	2 / 24 (8.33%)	3 / 70 (4.29%)
occurrences all number	7	1	2	4
Resorption bone increased
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Myalgia
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	1 / 24 (4.17%)	4 / 70 (5.71%)
occurrences all number	4	0	1	4
Infections and infestations
Oropharyngeal candidiasis
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Oral infection
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Nasopharyngitis
subjects affected / exposed	5 / 72 (6.94%)	0 / 8 (0.00%)	0 / 24 (0.00%)	12 / 70 (17.14%)
occurrences all number	5	0	0	12
Influenza
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	2 / 24 (8.33%)	3 / 70 (4.29%)
occurrences all number	3	0	2	3
Escherichia urinary tract infection
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0
Candida infection
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	1 / 70 (1.43%)
occurrences all number	0	1	0	1
Bronchitis
subjects affected / exposed	8 / 72 (11.11%)	0 / 8 (0.00%)	1 / 24 (4.17%)	5 / 70 (7.14%)
occurrences all number	10	0	1	6
Pneumonia
subjects affected / exposed	10 / 72 (13.89%)	0 / 8 (0.00%)	5 / 24 (20.83%)	12 / 70 (17.14%)
occurrences all number	13	0	5	13
Sinusitis
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	4 / 24 (16.67%)	2 / 70 (2.86%)
occurrences all number	1	0	4	4
Urinary tract infection
subjects affected / exposed	7 / 72 (9.72%)	0 / 8 (0.00%)	1 / 24 (4.17%)	5 / 70 (7.14%)
occurrences all number	10	0	3	5
Upper respiratory tract infection
subjects affected / exposed	14 / 72 (19.44%)	0 / 8 (0.00%)	3 / 24 (12.50%)	22 / 70 (31.43%)
occurrences all number	22	0	5	26
Respiratory tract infection
subjects affected / exposed	9 / 72 (12.50%)	0 / 8 (0.00%)	0 / 24 (0.00%)	6 / 70 (8.57%)
occurrences all number	13	0	0	6
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	12 / 72 (16.67%)	2 / 8 (25.00%)	2 / 24 (8.33%)	10 / 70 (14.29%)
occurrences all number	13	2	2	10
Dehydration
subjects affected / exposed	4 / 72 (5.56%)	0 / 8 (0.00%)	2 / 24 (8.33%)	1 / 70 (1.43%)
occurrences all number	4	0	2	1
Hypercalcaemia
subjects affected / exposed	7 / 72 (9.72%)	2 / 8 (25.00%)	0 / 24 (0.00%)	3 / 70 (4.29%)
occurrences all number	12	3	0	3
Hyperglycaemia
subjects affected / exposed	3 / 72 (4.17%)	0 / 8 (0.00%)	4 / 24 (16.67%)	10 / 70 (14.29%)
occurrences all number	8	0	4	19
Hyperkalaemia
subjects affected / exposed	2 / 72 (2.78%)	2 / 8 (25.00%)	1 / 24 (4.17%)	3 / 70 (4.29%)
occurrences all number	2	3	2	3
Hyperuricaemia
subjects affected / exposed	1 / 72 (1.39%)	0 / 8 (0.00%)	2 / 24 (8.33%)	3 / 70 (4.29%)
occurrences all number	1	0	3	3
Hypocalcaemia
subjects affected / exposed	5 / 72 (6.94%)	1 / 8 (12.50%)	3 / 24 (12.50%)	3 / 70 (4.29%)
occurrences all number	6	1	3	4
Hypokalaemia
subjects affected / exposed	5 / 72 (6.94%)	1 / 8 (12.50%)	4 / 24 (16.67%)	6 / 70 (8.57%)
occurrences all number	6	1	6	7
Hypomagnesaemia
subjects affected / exposed	9 / 72 (12.50%)	2 / 8 (25.00%)	5 / 24 (20.83%)	7 / 70 (10.00%)
occurrences all number	14	2	5	12
Hyponatraemia
subjects affected / exposed	3 / 72 (4.17%)	1 / 8 (12.50%)	3 / 24 (12.50%)	2 / 70 (2.86%)
occurrences all number	6	1	3	4
Hypophosphataemia
subjects affected / exposed	4 / 72 (5.56%)	1 / 8 (12.50%)	1 / 24 (4.17%)	4 / 70 (5.71%)
occurrences all number	4	1	2	4
Vitamin B1 deficiency
subjects affected / exposed	0 / 72 (0.00%)	1 / 8 (12.50%)	0 / 24 (0.00%)	0 / 70 (0.00%)
occurrences all number	0	1	0	0

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Were there any global substantial amendments to the protocol? Yes

22 May 2018

Incorporates changes required by the FDA per the partial clinical hold based on safety concerns from pembrolizumab studies, as well as study design and objective changes to reflect endpoints adequacy in light of these safety concerns. Incorporates new biomarker collections which align with the BMS multiple myeloma program level approach. Revision of efficacy assessments (Appendix III) to align with the current International Myeloma Working Group (IMWG) guidance.

12 Nov 2018

Enrollment into the study was stopped as of 23-August-2018. All efficacy assessments will be based on the investigator evaluation rather than Independent Review Committee (IRC). Bone marrow aspirate collection time-points and samples are reduced. Pharmacokinetic (PK), immunogenicity/antidrug-antibody (ADA) collections and quality of life (QOL) evaluations are cancelled. Update of Appendix 3 Definitions of Response and Progression criteria, Appendix 5 Nivolumab Management Algorithm and Appendix 6 Pomalidomide Pregnancy Risk Prevention Plan.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Due to the early enrolment termination to Study CA209602 and the smaller than planned study sample size, the statistical analyses were not sufficiently powered.

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Clinical trials

Clinical Trial Results:
An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma

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Primary: Progression Free Survival (PFS)

Primary: Progression Free Survival (PFS)

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Clinical trials

Clinical Trial Results: An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Progression Free Survival (PFS)

Primary: Progression Free Survival (PFS)

Secondary: Objective Response Rate (ORR)

Secondary: Objective Response Rate (ORR)

Secondary: Overall Survival (OS)

Secondary: Overall Survival (OS)

Secondary: Duration of Objective Response (DOR)

Secondary: Duration of Objective Response (DOR)

Secondary: Time to Objective Response (TTR)

Secondary: Time to Objective Response (TTR)

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Substantial protocol amendments (globally)

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Clinical Trial Results:
An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma