History of Changes for Study: NCT02076009

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

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Study Record Versions

Version	Submitted Date	Changes
1	February 27, 2014	None (earliest Version on record)
2	March 6, 2014	Outcome Measures, Study Status and Contacts/Locations
3	March 27, 2014	Contacts/Locations and Study Status
4	April 17, 2014	Study Status and Contacts/Locations
5	May 8, 2014	Study Status and Contacts/Locations
6	June 18, 2014	Recruitment Status, Contacts/Locations, Outcome Measures, Study Status, Study Design and Study Description
7	July 10, 2014	Contacts/Locations and Study Status
8	July 31, 2014	Contacts/Locations and Study Status
9	August 22, 2014	Contacts/Locations and Study Status
10	September 12, 2014	Contacts/Locations and Study Status
11	October 3, 2014	Contacts/Locations and Study Status
12	October 24, 2014	Contacts/Locations and Study Status
13	November 14, 2014	Contacts/Locations and Study Status
14	November 26, 2014	Contacts/Locations and Study Status
15	December 17, 2014	Contacts/Locations and Study Status
16	January 12, 2015	Study Status, Contacts/Locations and Eligibility
17	February 2, 2015	Contacts/Locations and Study Status
18	February 23, 2015	Contacts/Locations and Study Status
19	March 16, 2015	Contacts/Locations and Study Status
20	April 7, 2015	Contacts/Locations and Study Status
21	April 28, 2015	Contacts/Locations and Study Status
22	May 19, 2015	Contacts/Locations and Study Status
23	June 9, 2015	Contacts/Locations and Study Status
24	June 30, 2015	Contacts/Locations and Study Status
25	July 21, 2015	Contacts/Locations and Study Status
26	August 7, 2015	Recruitment Status, Contacts/Locations, Study Status and Study Design
27	November 23, 2015	Study Status and Study Design
28	February 26, 2016	Study Status
29	May 20, 2016	Study Status
30	June 23, 2016	Arms and Interventions, Study Status, Contacts/Locations and Study Description
31	September 21, 2016	Contacts/Locations, Study Status and Study Design
32	October 21, 2016	Study Status and Study Design
33	December 9, 2016	Outcome Measures, Study Status and Eligibility
34	December 20, 2016	Outcome Measures, Study Status and Results
35	February 16, 2017	Study Status, Baseline Characteristics, Study Design and Oversight
36	April 4, 2017	Study Status, Study Design and Oversight
37	June 1, 2017	Study Status and Oversight
38	July 27, 2017	Study Status
39	March 6, 2018	Study Status, Eligibility, Arms and Interventions and Study Description
40	January 31, 2019	Study Status
41	May 13, 2019	Study Status, Contacts/Locations and Study Design
42	June 13, 2019	Study Status and Study Design
43	August 22, 2019	Study Status
44	October 21, 2019	Study Status
45	January 7, 2020	Study Status
46	May 5, 2020	Arms and Interventions, Study Status and Study Description
47	June 25, 2020	Study Status
48	August 20, 2020	Study Status
49	October 15, 2020	Study Status and Contacts/Locations
50	January 8, 2021	Study Status
51	February 4, 2021	Study Status
52	March 4, 2021	Study Status
53	August 5, 2021	Baseline Characteristics, Study Status, Outcome Measures, Adverse Events, Arms and Interventions and Study Description
54	September 16, 2021	Study Status
55	October 14, 2021	Study Status
56	November 4, 2021	Contacts/Locations, Study Status and Study Design
57	December 2, 2021	Study Status and Contacts/Locations
58	December 30, 2021	Contacts/Locations and Study Status
59	January 27, 2022	Study Status
60	February 24, 2022	Study Status and Contacts/Locations
61	March 24, 2022	Study Status and Contacts/Locations
62	April 21, 2022	Study Status
63	May 19, 2022	Study Status
64	June 16, 2022	Study Status
65	July 14, 2022	Study Status
66	August 11, 2022	Study Status
67	September 8, 2022	Study Status
68	October 6, 2022	Study Status
69	November 3, 2022	Study Status
70	November 22, 2022	Study Status
71	December 20, 2022	Study Status
72	January 17, 2023	Study Status
73	February 14, 2023	Study Status
74	March 14, 2023	Study Status
75	April 4, 2023	Study Status and Contacts/Locations
76	April 12, 2023	Study Status
77	May 3, 2023	Study Status
78	May 30, 2023	Contacts/Locations and Study Status
79	June 28, 2023	Study Status
80	July 19, 2023	Study Status
81	August 15, 2023	Study Status and Study Design
82	September 12, 2023	Contacts/Locations and Study Status
83	October 10, 2023	Study Status
84	November 2, 2023	Adverse Events, Outcome Measures, Participant Flow, Baseline Characteristics and Study Status
85	December 5, 2023	Study Status
86	January 2, 2024	Study Status
87	January 30, 2024	Study Status
88	February 27, 2024	Study Status
89	March 26, 2024	Study Status
90	April 23, 2024	Study Status
91	May 21, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CR103663
Brief Title:	A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Official Title:	Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
Secondary IDs:	54767414MMY3003 [Janssen Research & Development, LLC] 2013-005525-23 [EudraCT Number]

Study Status


Record Verification:	June 2017
Overall Status:	Active, not recruiting
Study Start:	May 23, 2014
Primary Completion:	March 7, 2016 [Actual]
Study Completion:	September 29, 2020 [Anticipated]

First Submitted:	February 27, 2014
First Submitted that Met QC Criteria:	February 27, 2014
First Posted:	March 3, 2014 [Estimate]

Results First Submitted:	December 20, 2016
Results First Submitted that Met QC Criteria:	December 20, 2016
Results First Posted:	February 10, 2017 [Actual]

Last Update Submitted that Met QC Criteria:	June 1, 2017
Last Update Posted:	June 28, 2017 [Actual]

Sponsor/Collaborators


Sponsor:	Janssen Research & Development, LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief Summary:

The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

Detailed Description:

This is a randomized (participants will be assigned by chance to study treatments), open-label (all participants and study personnel will know the identity of the study treatments), active-controlled (none of the study treatments are placebo), parallel-group (both treatment arms will run at the same time), multicenter study. In this study, daratumumab, lenalidomide, and low-dose dexamethasone (DRd) will be compared with lenalidomide and low dose dexamethasone (Rd) in participants with relapsed or refractory multiple myeloma. Participants will be randomized in a 1:1 ratio to receive either DRd or Rd. The study will include a Screening Phase, a Treatment Phase (involving treatment cycles of approximately 28 days in length), and a Follow-up Phase. The Treatment Phase will extend from the administration of the first dose of study medication until disease progression or unacceptable toxicity. Participants will also discontinue study treatment if: they become pregnant; have their dose held for more than 28 days (or if 3 consecutive planned doses of daratumumab are missed for reasons other than toxicity); or for safety reasons (for example, adverse event). The Follow-up Phase will begin at the end of treatment and will continue until death, loss to follow-up, consent withdrawal for study participation, or study end, whichever occurs first. Eligible participants from Rd group who have had sponsor-confirmed disease progression will be offered the option for treatment with daratumumab monotherapy (of 28 days cycle). The primary endpoint will be progression-free survival (PFS). Analysis of the primary endpoint is anticipated to be performed at approximately 18 months after the last subject is randomized. Study end is anticipated at approximately 5 years after the last subject is randomized. Blood and urine samples will be obtained at time points during the study, together with bone marrow aspirates/biopsies and skeletal surveys. Participant safety will be assessed throughout the study.

Conditions


Conditions:	Multiple Myeloma
Keywords:	Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma Daratumumab Lenalidomide Dexamethasone

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	569 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Daratumumab + lenalidomide + dexamethasone During each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.	Drug: Daratumumab Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; once only (on Day 1) during treatment cycles 7 onwards. Drug: Lenalidomide Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle. Drug: Dexamethasone Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Active Comparator: Lenalidomide + dexamethasone During each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.	Drug: Lenalidomide Lenalidomide will be administered at a dose of 25 mg orally (by mouth) on Days 1 through 21 of each treatment cycle. Drug: Dexamethasone Dexamethasone (or equivalent in accordance with local standards) will be administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Active Comparator: Daratumumab monotherapy During each 28-day treatment cycle, participants will receive daratumumab alone in daratumumab monotherapy group.	Drug: Daratumumab Daratumumab 16mg/kg will be administered as an intravenous (IV) infusion (into the vein) as per the following schedule: once a week during treatment cycles 1 and 2; every 2 weeks during treatment cycles 3 to 6; once only (on Day 1) during treatment cycles 7 onwards.

Outcome Measures

[See Results Section.]


Primary Outcome Measures:
1.	Progression-free Survival (PFS) [ Time Frame: From randomization to either disease progression or death whichever occurs first until 3 years ] PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Secondary Outcome Measures:
1.	Time to Disease Progression (TTP) [ Time Frame: From randomization to disease progression until 3 years ] TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.
2.	Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better [ Time Frame: From randomization to disease progression (approximately up to 3 years) ] VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.
3.	Percentage of Participants With Negative Minimal Residual Disease (MRD) [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ] Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^- 4 threshold.
4.	Overall Response Rate [ Time Frame: From randomization to disease progression (approximately up to 3 years) ] Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
5.	Overall Survival (OS) [ Time Frame: Up to approximately 5 years (anticipated) after the last participant is randomized ] Overall survival was measured from the date of randomization to the date of the participant's death.
6.	Time to Response [ Time Frame: From randomization up to first documented CR or PR until 3 years ] Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.
7.	Duration of Response (DOR) [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ] DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Must have documented multiple myeloma and measurable disease Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen Must have documented evidence of progressive disease as defined by the International Myeloma Working Group criteria on or after their last regimen Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2 If a subject is receiving subsequent anticancer therapy (salvage therapy), the subject must have a "wash-out period" prior to receiving daratumumab monotherapy. This period is defined as 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the start date planned daratumumab monotherapy. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day for a maximum of 4 days) before Daratumumab monotherapy, which is permitted Exclusion Criteria: Has received any of the following therapies: daratumumab or other anti-CD38 therapies Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment Has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease History of malignancy (other than multiple myeloma) within 5 years before the first dose of daratumumab monotherapy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)

Contacts/Locations


Study Officials:	Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Locations:	United States, Arkansas
	Little Rock, Arkansas, United States
	United States, Florida
	Gainesville, Florida, United States
	West Palm Beach, Florida, United States
	United States, Georgia
	Atlanta, Georgia, United States
	United States, Illinois
	Chicago, Illinois, United States
	United States, Iowa
	Iowa City, Iowa, United States
	United States, Kentucky
	Louisville, Kentucky, United States
	United States, Louisiana
	Baton Rouge, Louisiana, United States
	New Orleans, Louisiana, United States
	United States, Maryland
	Bethesda, Maryland, United States
	Columbia, Maryland, United States
	United States, Massachusetts
	Boston, Massachusetts, United States
	United States, Minnesota
	Rochester, Minnesota, United States
	United States, Nebraska
	Omaha, Nebraska, United States
	United States, New Jersey
	New Brunswick, New Jersey, United States
	United States, New York
	New York, New York, United States
	United States, North Carolina
	Charlotte, North Carolina, United States
	United States, Oregon
	Eugene, Oregon, United States
	United States, South Carolina
	Spartanburg, South Carolina, United States
	United States, Texas
	Austin, Texas, United States
	Dallas, Texas, United States
	Houston, Texas, United States
	United States, Virginia
	Fairfax, Virginia, United States
	Australia
	Camperdown, Australia
	Geelong, Australia
	Heidelberg, Australia
	Malvern, Australia
	South Brisbane, Australia
	Southport, Australia
	Belgium
	Antwerpen, Belgium
	Brussel, Belgium
	Edegem, Belgium
	Gent, Belgium
	Kortrijk, Belgium
	Leuven, Belgium
	Liege, Belgium
	Canada
	Surrey N/A, Canada
	Toronto N/A, Canada
	Canada, Alberta
	Calgary, Alberta, Canada
	Edmonton, Alberta, Canada
	Canada, British Columbia
	Vancouver, British Columbia, Canada
	Canada, Nova Scotia
	Halifax, Nova Scotia, Canada
	Canada, Ontario
	Hamilton, Ontario, Canada
	London, Ontario, Canada
	Canada, Quebec
	Montreal, Quebec, Canada
	Quebec City, Quebec, Canada
	Denmark
	Copenhagen, Denmark
	Odense, Denmark
	Vejle, Denmark
	France
	Argenteuil, France
	Caen, France
	Lille, France
	Limoges, France
	Nantes Cedex 1, France
	Paris, France
	Pessac, France
	Pierre Benite, France
	Rennes, France
	Toulouse Cedex 9, France
	Tours Cedex 9, France
	Vandoeuvre Les Nancy, France
	Germany
	Berlin, Germany
	Bonn, Germany
	Hamburg, Germany
	Hamm, Germany
	Heidelberg, Germany
	Jena, Germany
	Karlsruhe, Germany
	Koblenz, Germany
	Köln, Germany
	Saarbrücken, Germany
	Villingen-Schwenningen, Germany
	Greece
	Athens Attica, Greece
	Israel
	Haifa, Israel
	Jerusalem, Israel
	Nahariya, Israel
	Netanya, Israel
	Petah Tikva, Israel
	Ramat Gan, Israel
	Tel Aviv, Israel
	Japan
	Hitachi, Japan
	Kanazawa, Japan
	Kobe, Japan
	Kurume, Japan
	Matsuyama, Japan
	Nagoya, Japan
	Narita, Japan
	Ohgaki, Japan
	Okayama, Japan
	Osaka, Japan
	Sendai, Japan
	Shibukawa, Japan
	Tachikawa, Japan
	Tokyo, Japan
	Korea, Republic of
	Gyeonggi-Do, Korea, Republic of
	Incheon, Korea, Republic of
	Seoul, Korea, Republic of
	Netherlands
	Amsterdam, Netherlands
	Rotterdam, Netherlands
	Utrecht, Netherlands
	Zwolle, Netherlands
	Poland
	Brzozow, Poland
	Chorzów, Poland
	Gdansk, Poland
	Legnica, Poland
	Lublin, Poland
	Poznan, Poland
	Slupsk, Poland
	Wroclawa, Poland
	Russian Federation
	Dzerzhinsk, Russian Federation
	Ekaterinburg, Russian Federation
	Moscow, Russian Federation
	Nizhny Novgorod, Russian Federation
	Petrozavodsk, Russian Federation
	Ryazan, Russian Federation
	Samara, Russian Federation
	St-Petersburg, Russian Federation
	St. Petersburg, Russian Federation
	Syktyvkar, Russian Federation
	Spain
	Badalona, Spain
	Barcelona, Spain
	La Laguna (Santa Cruz De Tenerife), Spain
	Madrid, Spain
	Pamplona, Spain
	Salamanca N/A, Spain
	Sevilla, Spain
	Sweden
	Falun, Sweden
	Göteborg, Sweden
	Helsingborg, Sweden
	Huddinge, Sweden
	Lund, Sweden
	Stockholm, Sweden
	Uppsala, Sweden
	Taiwan
	Changhua, Taiwan
	Taichung City, Taiwan
	Tainan, Taiwan
	Taipei, Taiwan
	Taoyuan, Taiwan
	United Kingdom
	Birmingham, United Kingdom
	Leeds, United Kingdom
	London, United Kingdom
	Oxford, United Kingdom
	Southampton, United Kingdom
	Surrey, United Kingdom
	Wolverhampton, United Kingdom

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information:

Participant Flow

Recruitment Details

Pre-assignment Details

Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Period Title: Overall Study
Started	283	286
Treated	281	283
Completed	0	0
Not Completed	283	286
Reason Not Completed
Death	44	30
Withdrawal by Subject	9	3
Lost to Follow-up	1	1
Progressive disease	1	0
Ongoing	226	249
Subjects randomized but not treated	2	3

Baseline Characteristics

Arm/Group Title

Lenalidomide, Low-dose Dexamethasone (Rd)

Daratumumab, Lenalidomide, Dexamethasone (DRd)

Total

Arm/Group Description

Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).

Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Total of all reporting groups

Overall Number of Baseline Participants

283

286

569

Baseline Analysis Population Description

[Not Specified]

Age, Continuous

Mean (Standard Deviation)
Unit of measure: years

Number Analyzed

283 Participants

286 Participants

569 Participants

64.3(8.84)

64.4(9.03)

64.4(8.93)

Sex: Female, Male

Measure Type: Count of Participants
Unit of measure: Participants

Number Analyzed

283 Participants

286 Participants

569 Participants

Female

119

42.05%

113

39.51%

232

40.77%

Male

164

57.95%

173

60.49%

337

59.23%

Region of Enrollment

Measure Type: Number
Unit of measure: participants

Number Analyzed

283 Participants

286 Participants

569 Participants

Australia

Belgium

Canada

Denmark

France

Germany

Greece

Israel

Japan

Korea, Republic of

Netherlands

Poland

Russian Federation

Spain

Sweden

Taiwan, Province of China

United Kingdom

United States

Stage of Disease (ISS)^[1]

Measure Type: Number
Unit of measure: participants

Number Analyzed

283 Participants

286 Participants

569 Participants

140

137

277

179

III

113

[1]

Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (>=) 3.5 gram per 100 Milliliter (g/100 ml); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/l.

No. of Prior Lines of Therapy

Measure Type: Number
Unit of measure: participants

Number Analyzed

283 Participants

286 Participants

569 Participants

146

149

295

165

Outcome Measures

1. Primary Outcome:

Title

Progression-free Survival (PFS)

Description

PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

Time Frame

From randomization to either disease progression or death whichever occurs first until 3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	283	286
Median (95% Confidence Interval) Unit of Measure: months	18.43(13.86 to NA)^[1]	NA(NA to NA)^[2]

[1]	NA Explanation: Upper limit of 95% confidence interval (CI) was not estimable due to short follow-up by participants.
[2]	NA Explanation: Median and 95% CI was not estimable due to short follow-up by participants.

2. Secondary Outcome:

Title

Time to Disease Progression (TTP)

Description

TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.

Time Frame

From randomization to disease progression until 3 years

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	283	286
Median (95% Confidence Interval) Unit of Measure: months	18.43(14.78 to NA)^[1]	NA(NA to NA)^[2]

[1]	NA Explanation: Upper limit of 95% CI was not estimable due to short follow-up.
[2]	NA Explanation: Median and 95% CI was not estimable due to short follow-up.

3. Secondary Outcome:

Title

Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better

Description

VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.

Time Frame

From randomization to disease progression (approximately up to 3 years)

Outcome Measure Data

Analysis Population Description

Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	276	281
Number (95% Confidence Interval) Unit of Measure: percentage of participants	44.2(38.3 to 50.3)	75.8(70.4 to 80.7)

4. Secondary Outcome:

Title

Percentage of Participants With Negative Minimal Residual Disease (MRD)

Description

Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^- 4 threshold.

Time Frame

From randomization to the date of first documented evidence of PD until 3 years

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	283	286
Measure Type: Number Unit of Measure: percentage of participants	7.8	29.0

5. Secondary Outcome:

Title

Overall Response Rate

Description

Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

Time Frame

From randomization to disease progression (approximately up to 3 years)

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	276	281
Measure Type: Number Unit of Measure: percentage of participants	76.4	92.9

6. Secondary Outcome:

Title

Overall Survival (OS)

Description

Overall survival was measured from the date of randomization to the date of the participant's death.

Time Frame

Up to approximately 5 years (anticipated) after the last participant is randomized

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	283	286
Median (95% Confidence Interval) Unit of Measure: months	NA(NA to NA)^[1]	NA(NA to NA)^[1]

[1]	NA Explanation: Data was not calculated and reported due to short follow-up by participants.

7. Secondary Outcome:

Title

Time to Response

Description

Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.

Time Frame

From randomization up to first documented CR or PR until 3 years

Outcome Measure Data

Analysis Population Description

Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	276	281
Median (95% Confidence Interval) Unit of Measure: months	1.3(1.1 to 1.9)	1.0(1.0 to 1.1)

8. Secondary Outcome:

Title

Duration of Response (DOR)

Description

DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.

Time Frame

From randomization to the date of first documented evidence of PD until 3 years

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Overall Number of Participants Analyzed	211	261
Median (95% Confidence Interval) Unit of Measure: months	17.4(17.4 to NA)^[1]	NA(NA to NA)^[2]

[1]	NA Explanation: Upper limit of 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.
[2]	NA Explanation: Median and 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.

Adverse Events


Time Frame	[Not specified]
Adverse Event Reporting Description	Safety Population included participants who were randomized and received at least 1 dose of any study treatment.

Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).	Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
All-Cause Mortality
	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
	Affected / At Risk (%)	Affected / At Risk (%)
Total	/	/
Serious Adverse Events
	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
	Affected / At Risk (%)	Affected / At Risk (%)
Total	118 / 281 (41.99%)	138 / 283 (48.76%)
Blood and lymphatic system disorders
Anaemia ^{∗ A}	2 / 281 (0.71%)	2 / 283 (0.71%)
Bone Marrow Failure ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Febrile Neutropenia ^{∗ A}	4 / 281 (1.42%)	12 / 283 (4.24%)
Hyperviscosity Syndrome ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Lymphadenopathy ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Neutropenia ^{∗ A}	0 / 281 (0%)	2 / 283 (0.71%)
Sideroblastic Anaemia ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Thrombocytopenia ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Thrombotic Thrombocytopenic Purpura ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Cardiac disorders
Acute Coronary Syndrome ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Acute Myocardial Infarction ^{∗ A}	3 / 281 (1.07%)	0 / 283 (0%)
Angina Pectoris ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Atrial Fibrillation ^{∗ A}	2 / 281 (0.71%)	2 / 283 (0.71%)
Atrial Flutter ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Cardiac Amyloidosis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Cardiac Arrest ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Cardiac Failure Congestive ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Cardiopulmonary Failure ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Myocardial Infarction ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Pericarditis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Sinus Arrhythmia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Supraventricular Tachycardia ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Eye disorders
Cataract ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Posterior Capsule Rupture ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Gastrointestinal disorders
Colitis ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Constipation ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Diarrhoea ^{∗ A}	6 / 281 (2.14%)	5 / 283 (1.77%)
Diverticular Perforation ^{∗ A}	0 / 281 (0%)	2 / 283 (0.71%)
Gastrointestinal Angiodysplasia Haemorrhagic ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Gastrointestinal Disorder ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Haematemesis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Inguinal Hernia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Intestinal Obstruction ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Lower Gastrointestinal Haemorrhage ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Nausea ^{∗ A}	0 / 281 (0%)	2 / 283 (0.71%)
Oesophagitis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Vomiting ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
General disorders
Asthenia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Chest Discomfort ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Fatigue ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Gait Disturbance ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
General Physical Health Deterioration ^{∗ A}	0 / 281 (0%)	2 / 283 (0.71%)
Generalised Oedema ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Multi-Organ Failure ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Non-Cardiac Chest Pain ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Pain ^{∗ A}	2 / 281 (0.71%)	1 / 283 (0.35%)
Pyrexia ^{∗ A}	4 / 281 (1.42%)	8 / 283 (2.83%)
Systemic Inflammatory Response Syndrome ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Hepatobiliary disorders
Bile Duct Stone ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Liver Disorder ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Infections and infestations
Acute Sinusitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Anal Abscess ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Appendicitis ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Bacterial Infection ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Bronchiolitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Bronchitis ^{∗ A}	4 / 281 (1.42%)	5 / 283 (1.77%)
Bronchitis Bacterial ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Bronchopneumonia ^{∗ A}	0 / 281 (0%)	2 / 283 (0.71%)
Candida Infection ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Cellulitis ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Clostridium Difficile Infection ^{∗ A}	2 / 281 (0.71%)	0 / 283 (0%)
Cytomegalovirus Infection ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Enterocolitis Infectious ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Epiglottitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Erysipelas ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Escherichia Bacteraemia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Extradural Abscess ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Gastroenteritis ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Gastroenteritis Viral ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Gastrointestinal Infection ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Gingivitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
H1n1 Influenza ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Haemophilus Infection ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Infection ^{∗ A}	3 / 281 (1.07%)	2 / 283 (0.71%)
Infective Spondylitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Influenza ^{∗ A}	4 / 281 (1.42%)	8 / 283 (2.83%)
Keratitis Fungal ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Listeria Sepsis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Lobar Pneumonia ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Lower Respiratory Tract Infection ^{∗ A}	3 / 281 (1.07%)	7 / 283 (2.47%)
Lung Infection ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Nasal Abscess ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Necrotising Fasciitis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Neutropenic Sepsis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Oral Fungal Infection ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Osteomyelitis ^{∗ A}	2 / 281 (0.71%)	0 / 283 (0%)
Parainfluenzae Virus Infection ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Parotitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Periorbital Cellulitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Pharyngitis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Pneumonia ^{∗ A}	24 / 281 (8.54%)	23 / 283 (8.13%)
Pneumonia Bacterial ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Pneumonia Haemophilus ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Pneumonia Influenzal ^{∗ A}	0 / 281 (0%)	3 / 283 (1.06%)
Pneumonia Klebsiella ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Pneumonia Legionella ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Pneumonia Streptococcal ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Pulmonary Tuberculosis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Pyelonephritis Acute ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Respiratory Syncytial Virus Infection ^{∗ A}	0 / 281 (0%)	2 / 283 (0.71%)
Respiratory Tract Infection ^{∗ A}	2 / 281 (0.71%)	5 / 283 (1.77%)
Respiratory Tract Infection Viral ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Salmonella Bacteraemia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Sepsis ^{∗ A}	5 / 281 (1.78%)	2 / 283 (0.71%)
Septic Shock ^{∗ A}	1 / 281 (0.36%)	3 / 283 (1.06%)
Skin Infection ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Soft Tissue Infection ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Tonsillitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Upper Respiratory Tract Infection ^{∗ A}	5 / 281 (1.78%)	1 / 283 (0.35%)
Upper Respiratory Tract Infection Bacterial ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Urinary Tract Infection ^{∗ A}	1 / 281 (0.36%)	3 / 283 (1.06%)
Urosepsis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Uterine Abscess ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Varicella Zoster Virus Infection ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Viral Infection ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Injury, poisoning and procedural complications
Compression Fracture ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Fall ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Femoral Neck Fracture ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Foot Fracture ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Hand Fracture ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Hip Fracture ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Humerus Fracture ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Joint Dislocation ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Pelvic Fracture ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Peroneal Nerve Injury ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Radius Fracture ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Rib Fracture ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Spinal Compression Fracture ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Subdural Haematoma ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Investigations
Body Temperature Increased ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Diagnostic Procedure ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
International Normalised Ratio Increased ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Troponin Increased ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Metabolism and nutrition disorders
Decreased Appetite ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Dehydration ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Electrolyte Imbalance ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Gout ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Hypercalcaemia ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Hyperglycaemia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Hypocalcaemia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Musculoskeletal and connective tissue disorders
Back Pain ^{∗ A}	5 / 281 (1.78%)	2 / 283 (0.71%)
Bone Pain ^{∗ A}	0 / 281 (0%)	2 / 283 (0.71%)
Flank Pain ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Intervertebral Disc Protrusion ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Muscular Weakness ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Musculoskeletal Pain ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Osteonecrosis of Jaw ^{∗ A}	2 / 281 (0.71%)	0 / 283 (0%)
Pain in Extremity ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Pathological Fracture ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Spinal Column Stenosis ^{∗ A}	2 / 281 (0.71%)	0 / 283 (0%)
Spinal Pain ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Monocytic Leukaemia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Benign Anorectal Neoplasm ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Bladder Transitional Cell Carcinoma ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Bowen's Disease ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Epstein-Barr Virus Associated Lymphoproliferative Disorder ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Lung Adenocarcinoma ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Plasma Cell Leukaemia ^{∗ A}	2 / 281 (0.71%)	1 / 283 (0.35%)
Prostate Cancer ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Rectal Adenocarcinoma ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Squamous Cell Carcinoma ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Nervous system disorders
Aphasia ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Carotid Arteriosclerosis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Cerebral Haemorrhage ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Cerebral Infarction ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Cognitive Disorder ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Intercostal Neuralgia ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Ischaemic Stroke ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Loss of Consciousness ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Nervous System Disorder ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Peripheral Sensory Neuropathy ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Presyncope ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Seizure ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Somnolence ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Syncope ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Transient Ischaemic Attack ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Trigeminal Nerve Disorder ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Viith Nerve Paralysis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Psychiatric disorders
Confusional State ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Depression ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Depressive Symptom ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Renal and urinary disorders
Acute Kidney Injury ^{∗ A}	8 / 281 (2.85%)	3 / 283 (1.06%)
Azotaemia ^{∗ A}	1 / 281 (0.36%)	1 / 283 (0.35%)
Renal Failure ^{∗ A}	3 / 281 (1.07%)	1 / 283 (0.35%)
Urethral Haemorrhage ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Reproductive system and breast disorders
Prostatomegaly ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Acute Respiratory Failure ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Bronchospasm ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Dyspnoea ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Hypoxia ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Interstitial Lung Disease ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Lung Disorder ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Pneumonitis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Pneumothorax ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Pulmonary Calcification ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Pulmonary Embolism ^{∗ A}	8 / 281 (2.85%)	7 / 283 (2.47%)
Pulmonary Oedema ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Respiratory Failure ^{∗ A}	1 / 281 (0.36%)	2 / 283 (0.71%)
Skin and subcutaneous tissue disorders
Rash Generalised ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Rash Papular ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Vascular disorders
Deep Vein Thrombosis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Embolism ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Haemorrhagic Infarction ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Hypertension ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Hypotension ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Orthostatic Hypotension ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Peripheral Artery Stenosis ^{∗ A}	0 / 281 (0%)	1 / 283 (0.35%)
Phlebitis ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
Venous Occlusion ^{∗ A}	1 / 281 (0.36%)	0 / 283 (0%)
∗Indicates events were collected by non-systematic methods. ATerm from vocabulary, MedDRA Version 18.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
	Affected / At Risk (%)	Affected / At Risk (%)
Total	274 / 281 (97.51%)	276 / 283 (97.53%)
Blood and lymphatic system disorders
Anaemia ^{∗ A}	98 / 281 (34.88%)	87 / 283 (30.74%)
Leukopenia ^{∗ A}	17 / 281 (6.05%)	21 / 283 (7.42%)
Lymphopenia ^{∗ A}	15 / 281 (5.34%)	17 / 283 (6.01%)
Neutropenia ^{∗ A}	121 / 281 (43.06%)	168 / 283 (59.36%)
Thrombocytopenia ^{∗ A}	77 / 281 (27.4%)	76 / 283 (26.86%)
Eye disorders
Cataract ^{∗ A}	8 / 281 (2.85%)	18 / 283 (6.36%)
Vision Blurred ^{∗ A}	14 / 281 (4.98%)	19 / 283 (6.71%)
Gastrointestinal disorders
Abdominal Pain ^{∗ A}	11 / 281 (3.91%)	20 / 283 (7.07%)
Abdominal Pain Upper ^{∗ A}	10 / 281 (3.56%)	21 / 283 (7.42%)
Constipation ^{∗ A}	71 / 281 (25.27%)	82 / 283 (28.98%)
Diarrhoea ^{∗ A}	65 / 281 (23.13%)	121 / 283 (42.76%)
Dyspepsia ^{∗ A}	6 / 281 (2.14%)	18 / 283 (6.36%)
Nausea ^{∗ A}	40 / 281 (14.23%)	67 / 283 (23.67%)
Stomatitis ^{∗ A}	6 / 281 (2.14%)	17 / 283 (6.01%)
Vomiting ^{∗ A}	14 / 281 (4.98%)	46 / 283 (16.25%)
General disorders
Asthenia ^{∗ A}	36 / 281 (12.81%)	45 / 283 (15.9%)
Chills ^{∗ A}	9 / 281 (3.2%)	17 / 283 (6.01%)
Fatigue ^{∗ A}	78 / 281 (27.76%)	100 / 283 (35.34%)
Influenza Like Illness ^{∗ A}	12 / 281 (4.27%)	17 / 283 (6.01%)
Oedema Peripheral ^{∗ A}	37 / 281 (13.17%)	43 / 283 (15.19%)
Pyrexia ^{∗ A}	30 / 281 (10.68%)	53 / 283 (18.73%)
Infections and infestations
Bronchitis ^{∗ A}	31 / 281 (11.03%)	36 / 283 (12.72%)
Nasopharyngitis ^{∗ A}	43 / 281 (15.3%)	68 / 283 (24.03%)
Pneumonia ^{∗ A}	17 / 281 (6.05%)	20 / 283 (7.07%)
Respiratory Tract Infection ^{∗ A}	22 / 281 (7.83%)	28 / 283 (9.89%)
Rhinitis ^{∗ A}	3 / 281 (1.07%)	15 / 283 (5.3%)
Sinusitis ^{∗ A}	10 / 281 (3.56%)	18 / 283 (6.36%)
Upper Respiratory Tract Infection ^{∗ A}	54 / 281 (19.22%)	89 / 283 (31.45%)
Investigations
Alanine Aminotransferase Increased ^{∗ A}	10 / 281 (3.56%)	15 / 283 (5.3%)
Weight Decreased ^{∗ A}	9 / 281 (3.2%)	16 / 283 (5.65%)
Metabolism and nutrition disorders
Decreased Appetite ^{∗ A}	28 / 281 (9.96%)	32 / 283 (11.31%)
Hyperglycaemia ^{∗ A}	19 / 281 (6.76%)	25 / 283 (8.83%)
Hypocalcaemia ^{∗ A}	11 / 281 (3.91%)	17 / 283 (6.01%)
Hypokalaemia ^{∗ A}	22 / 281 (7.83%)	30 / 283 (10.6%)
Hypophosphataemia ^{∗ A}	11 / 281 (3.91%)	16 / 283 (5.65%)
Musculoskeletal and connective tissue disorders
Arthralgia ^{∗ A}	21 / 281 (7.47%)	24 / 283 (8.48%)
Back Pain ^{∗ A}	45 / 281 (16.01%)	49 / 283 (17.31%)
Bone Pain ^{∗ A}	12 / 281 (4.27%)	17 / 283 (6.01%)
Muscle Spasms ^{∗ A}	52 / 281 (18.51%)	73 / 283 (25.8%)
Muscular Weakness ^{∗ A}	21 / 281 (7.47%)	23 / 283 (8.13%)
Musculoskeletal Chest Pain ^{∗ A}	17 / 281 (6.05%)	15 / 283 (5.3%)
Musculoskeletal Pain ^{∗ A}	15 / 281 (5.34%)	17 / 283 (6.01%)
Myalgia ^{∗ A}	9 / 281 (3.2%)	16 / 283 (5.65%)
Pain in Extremity ^{∗ A}	30 / 281 (10.68%)	20 / 283 (7.07%)
Nervous system disorders
Dizziness ^{∗ A}	24 / 281 (8.54%)	22 / 283 (7.77%)
Dysgeusia ^{∗ A}	15 / 281 (5.34%)	21 / 283 (7.42%)
Headache ^{∗ A}	19 / 281 (6.76%)	37 / 283 (13.07%)
Neuropathy Peripheral ^{∗ A}	15 / 281 (5.34%)	12 / 283 (4.24%)
Peripheral Sensory Neuropathy ^{∗ A}	18 / 281 (6.41%)	23 / 283 (8.13%)
Tremor ^{∗ A}	24 / 281 (8.54%)	26 / 283 (9.19%)
Psychiatric disorders
Anxiety ^{∗ A}	12 / 281 (4.27%)	18 / 283 (6.36%)
Depression ^{∗ A}	5 / 281 (1.78%)	17 / 283 (6.01%)
Insomnia ^{∗ A}	55 / 281 (19.57%)	55 / 283 (19.43%)
Renal and urinary disorders
Renal Impairment ^{∗ A}	13 / 281 (4.63%)	20 / 283 (7.07%)
Respiratory, thoracic and mediastinal disorders
Cough ^{∗ A}	35 / 281 (12.46%)	82 / 283 (28.98%)
Dyspnoea ^{∗ A}	32 / 281 (11.39%)	51 / 283 (18.02%)
Skin and subcutaneous tissue disorders
Hyperhidrosis ^{∗ A}	8 / 281 (2.85%)	20 / 283 (7.07%)
Pruritus ^{∗ A}	29 / 281 (10.32%)	28 / 283 (9.89%)
Rash ^{∗ A}	29 / 281 (10.32%)	35 / 283 (12.37%)
Vascular disorders
Hypertension ^{∗ A}	7 / 281 (2.49%)	20 / 283 (7.07%)
Hypotension ^{∗ A}	6 / 281 (2.14%)	19 / 283 (6.71%)
∗Indicates events were collected by non-systematic methods. ATerm from vocabulary, MedDRA Version 18.0

Limitations and Caveats


[Not specified]

More Information


Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact:
Name/Official Title:	Director, Clinical Research
Organization:	Janssen R&D US
Phone:
Email:	ClinicalTrialDisclosure@its.jnj.com