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Trial record 3 of 25 for:    "Angiomatous lymphoid hamartoma"

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

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ClinicalTrials.gov Identifier: NCT01024036
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : August 20, 2014
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multicentric Castleman's Disease
Interventions Drug: Siltuximab
Drug: Placebo
Drug: Best Supportive Care (BSC)
Enrollment 79
Recruitment Details 79 participants were enrolled at 38 study centers in 19 countries. The first participant signed the informed consent on 09 Feb 2010, and the last participant's last visit for the primary analysis was 28 Feb 2013. The data until the end of study is presented here.
Pre-assignment Details 79 participants were enrolled, randomized and treated during the blinded treatment period. 53 received siltuximab+best supportive care (BSC) and 26 received placebo+BSC.13 participants who did not respond to placebo+BSC during the blinded treatment period, received siltuximab+BSC during the unblinded treatment period.
Arm/Group Title Siltuximab + Best Supportive Care (BSC) Placebo + Best Supportive Care (BSC)
Hide Arm/Group Description Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Period Title: Blinded Treatment
Started 53 26
Completed 31 6
Not Completed 22 20
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             16             14
Physician Decision             1             0
Death             0             2
Withdrawal by Subject             4             3
Period Title: Unblinded Treatment
Started 0 [1] 13 [2]
Completed 0 10
Not Completed 0 3
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             0             2
[1]
No participants in this group received treatment during unblinded treatment period
[2]
Placebo participants had an option to receive siltuximab in unblinded treatment period
Period Title: Follow-Up Period
Started [1] 14 6
Completed 9 3
Not Completed 5 3
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             0             1
Adverse Event             4             1
[1]
Any participant who discontinued blinded/unblinded treatment could entered Follow-up period
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC) Total
Hide Arm/Group Description Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier. Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier. Total of all reporting groups
Overall Number of Baseline Participants 26 53 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 53 participants 79 participants
47.7  (13.4) 44.4  (13.32) 45.5  (13.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 53 participants 79 participants
Female
4
  15.4%
23
  43.4%
27
  34.2%
Male
22
  84.6%
30
  56.6%
52
  65.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 53 participants 79 participants
AUSTRALIA
0
   0.0%
1
   1.9%
1
   1.3%
BELGIUM
0
   0.0%
3
   5.7%
3
   3.8%
BRAZIL
2
   7.7%
4
   7.5%
6
   7.6%
CANADA
1
   3.8%
0
   0.0%
1
   1.3%
CHINA
5
  19.2%
11
  20.8%
16
  20.3%
EGYPT
1
   3.8%
0
   0.0%
1
   1.3%
FRANCE
2
   7.7%
2
   3.8%
4
   5.1%
GERMANY
1
   3.8%
0
   0.0%
1
   1.3%
HONG KONG
2
   7.7%
3
   5.7%
5
   6.3%
ISRAEL
1
   3.8%
1
   1.9%
2
   2.5%
NEW ZEALAND
1
   3.8%
1
   1.9%
2
   2.5%
NORWAY
1
   3.8%
1
   1.9%
2
   2.5%
RUSSIAN FEDERATION
0
   0.0%
3
   5.7%
3
   3.8%
SINGAPORE
0
   0.0%
3
   5.7%
3
   3.8%
SOUTH KOREA
2
   7.7%
4
   7.5%
6
   7.6%
SPAIN
1
   3.8%
1
   1.9%
2
   2.5%
TAIWAN
1
   3.8%
3
   5.7%
4
   5.1%
UNITED KINGDOM
1
   3.8%
2
   3.8%
3
   3.8%
UNITED STATES
4
  15.4%
10
  18.9%
14
  17.7%
1.Primary Outcome
Title Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review
Hide Description Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care [BSC] minus Placebo+BSC).
Time Frame From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all randomized participants.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 26 53
Measure Type: Number
Unit of Measure: Percentage of participants
0 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Best Supportive Care (BSC), Siltuximab + Best Supportive Care (BSC)
Comments Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for the stratification factor: corticosteroid use
Method of Estimation Estimation Parameter difference in the response rate
Estimated Value 34
Confidence Interval (2-Sided) 95%
11.1 to 54.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo + Best Supportive Care (BSC), Siltuximab + Best Supportive Care (BSC)
Comments Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Fisher Exact
Comments Without adjusting for the stratification factor: corticosteroid use
Method of Estimation Estimation Parameter difference in the response rate
Estimated Value 34.0
Confidence Interval (2-Sided) 95%
11.1 to 54.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review
Hide Description Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. Symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.
Time Frame From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who achieved durable tumor and symptomatic response during blinded treatment period as per independent review.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 0 18
Median (Full Range)
Unit of Measure: Days
383.0
(232 to 676)
3.Secondary Outcome
Title Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review
Hide Description Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).
Time Frame From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable Population: included participants who received at least 1 administration of siltuximab/placebo and had at least 1 post-baseline radiologic disease evaluation.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 26 53
Measure Type: Number
Unit of Measure: Percentage of participants
3.8 37.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Best Supportive Care (BSC), Siltuximab + Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in overall response rates
Estimated Value 33.9
Confidence Interval (2-Sided) 95%
11.1 to 54.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Median Duration of Tumor Response - by Independent Radiology Review
Hide Description Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).
Time Frame From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who achieved tumor response during blinded treatment period as per independent review.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 1 20
Median (Full Range)
Unit of Measure: Days
70
(70 to 70)
356
(55 to 674)
5.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman’s disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC).
Time Frame From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all randomized participants.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 26 53
Median (95% Confidence Interval)
Unit of Measure: Days
134 [1] 
(85 to NA)
NA [2] 
(378 to NA)
[1]
The upper limit was not estimable due to insufficient number of participants with event.
[2]
Median time to treatment failure was not estimable due to insufficient number of participants with event.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Best Supportive Care (BSC), Siltuximab + Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0084
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.418
Confidence Interval (2-Sided) 95%
0.214 to 0.815
Estimation Comments Hazard ratio and 95% CI from a Cox proportional hazards model
6.Secondary Outcome
Title Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)
Hide Description Hemoglobin response rate is defined as percentage of participants who achieved >= 15 g/L hemoglobin at Week 13.
Time Frame Week 13
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 postbaseline hemoglobin evaluation.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 11 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 61.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Best Supportive Care (BSC), Siltuximab + Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of hemoglobin response rates
Estimated Value 61.3
Confidence Interval (2-Sided) 95%
28.3 to 85.1
Estimation Comments Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care [BSC] arm minus hemoglobin response rate for Placebo+BSC arm.
7.Secondary Outcome
Title Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)
Hide Description Hemoglobin response rate is defined as percentage of participants who achieved >= 20 g/L hemoglobin at Week 13.
Time Frame Week 13
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 post-baseline hemoglobin evaluation.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 11 31
Measure Type: Number
Unit of Measure: Percentage of participants
0 41.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Best Supportive Care (BSC), Siltuximab + Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0195
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of hemoglobin response rates
Estimated Value 41.9
Confidence Interval (2-Sided) 95%
7.8 to 70.7
Estimation Comments Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care [BSC] arm minus hemoglobin response rate for Placebo+BSC arm.
8.Secondary Outcome
Title Percentage of Participants Who Discontinued Corticosteroids
Hide Description Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1).
Time Frame From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were dependent on corticosteroids at baseline.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 9 13
Measure Type: Number
Unit of Measure: Percentage of participants
11.1 30.8
9.Secondary Outcome
Title 6-year Survival Rate
Hide Description Overall survival was defined as percent chance of survival of participants who were still alive at 6 years from time of first study treatment was analyzed.
Time Frame until 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis set included all randomized participants who received at least 1 dose of study agent.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 26 53
Median (95% Confidence Interval)
Unit of Measure: Percent chance of survival
79.5
(57.5 to 91.0)
86.3
(71.9 to 93.6)
10.Secondary Outcome
Title Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman’s Disease Symptom Scale (MCD-SS) Score From Baseline
Hide Description A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe).
Time Frame From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all randomized participants.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 26 53
Median (Full Range)
Unit of Measure: Days
262 [1] 
(40 to NA)
85
(22 to 379)
[1]
The upper limit was not estimable due to insufficient number of participants with event.
11.Secondary Outcome
Title Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline
Hide Description The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from “not at all” (0) to “very much” (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes.
Time Frame From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all randomized participants.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 26 53
Median (95% Confidence Interval)
Unit of Measure: Days
22
(8 to 64)
15
(8 to 23)
12.Secondary Outcome
Title Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline
Hide Description SF-36 is a questionnaire and PCS is a part of subscale assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life.
Time Frame From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all randomized participants.
Arm/Group Title Placebo + Best Supportive Care (BSC) Siltuximab + Best Supportive Care (BSC)
Hide Arm/Group Description:
Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Overall Number of Participants Analyzed 26 53
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(169 to NA)
420 [2] 
(106 to NA)
[1]
Median time was not estimable due to insufficient number of participants with event.
[2]
The upper limit was not estimable due to insufficient number of participants with event.
Time Frame Up to 7 years
Adverse Event Reporting Description Safety Analysis set included all participants who received at least 1 dose of study drug in blinded and unblinded treatment period until 48 weeks after the last subject started study treatment (approximately 3 years). Participants who continued in the study from Week 48 through the end-of-study (5 years after the last participant started study treatment) were included in the Follow-up analysis set.
 
Arm/Group Title Placebo + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Unblinded) Placebo + BSC (Follow-up Period) Siltuximab + BSC (Follow-up Period)
Hide Arm/Group Description Participants received placebo as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued or completed treatment period up to Week 48, and who consented to enter the follow-up period were continued to be followed up during the course of follow-up period. Participants received siltuximab 11mg/kg as a 1-hour intravenous infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from the study, or until 48 weeks after the last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason completed the end-of-treatment visit and entered the follow-up period. Participants who had documented treatment failure and wished to continue treatment, their treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab during the unblinded treatment period. No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [placebo as a 1 hour IV infusion every 3 weeks along with BSC]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier. No study treatment was administered during the follow-up period (up to 3 months after last study agent administration [siltuximab 11mg/kg as a 1 hour IV infusion every 3 weeks along with ]) and participants were followed until death, lost to follow up, withdrawal of consent, death of 50 % of participants, or the end of the study, whichever occurred earlier.
All-Cause Mortality
Placebo + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Unblinded) Placebo + BSC (Follow-up Period) Siltuximab + BSC (Follow-up Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Unblinded) Placebo + BSC (Follow-up Period) Siltuximab + BSC (Follow-up Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/26 (26.92%)   12/53 (22.64%)   4/13 (30.77%)   1/6 (16.67%)   3/14 (21.43%) 
Cardiac disorders           
Cardiac Failure Congestive * 1  1/26 (3.85%)  0/53 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Endocrine disorders           
Hyperthyroidism * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Eye disorders           
Vitreous Haemorrhage * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Gastrointestinal disorders           
Dysphagia * 1  1/26 (3.85%)  0/53 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Umbilical Hernia * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
General disorders           
Oedema * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Oedema Peripheral * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Hepatobiliary disorders           
Cholecystitis Chronic * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Cholelithiasis * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Immune system disorders           
Anaphylactic Reaction * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Infections and infestations           
Anal Abscess * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Bronchitis * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Lower Respiratory Tract Infection * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Lung Infection * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Pneumonia * 1  3/26 (11.54%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Sepsis * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Injury, poisoning and procedural complications           
Accidental Overdose * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Tibia Fracture * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Wound Secretion * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Investigations           
Mycobacterium Test * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders           
Muscle Spasms * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Poems Syndrome * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
T-Cell Lymphoma * 1  1/26 (3.85%)  0/53 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders           
Dysuria * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Renal Colic * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Ureteral Disorder * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea * 1  2/26 (7.69%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Pleural Effusion * 1  3/26 (11.54%)  1/53 (1.89%)  2/13 (15.38%)  1/6 (16.67%)  0/14 (0.00%) 
Surgical and medical procedures           
Pain Management * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Vascular disorders           
Hypertensive Crisis * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Blinded) Siltuximab + Best Supportive Care (BSC) (Unblinded) Placebo + BSC (Follow-up Period) Siltuximab + BSC (Follow-up Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/26 (96.15%)   53/53 (100.00%)   13/13 (100.00%)   5/6 (83.33%)   14/14 (100.00%) 
Blood and lymphatic system disorders           
Anaemia * 1  5/26 (19.23%)  5/53 (9.43%)  4/13 (30.77%)  2/6 (33.33%)  2/14 (14.29%) 
Leukopenia * 1  2/26 (7.69%)  3/53 (5.66%)  1/13 (7.69%)  2/6 (33.33%)  1/14 (7.14%) 
Lymphopenia * 1  3/26 (11.54%)  0/53 (0.00%)  2/13 (15.38%)  1/6 (16.67%)  0/14 (0.00%) 
Neutropenia * 1  3/26 (11.54%)  7/53 (13.21%)  2/13 (15.38%)  2/6 (33.33%)  1/14 (7.14%) 
Thrombocytopenia * 1  2/26 (7.69%)  8/53 (15.09%)  1/13 (7.69%)  1/6 (16.67%)  3/14 (21.43%) 
Coagulopathy * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Leukocytosis * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Lymph Node Pain * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Monocytosis * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Neutrophilia * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Splenomegaly * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Cardiac disorders           
Bradycardia * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Ventricular Extrasystoles * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Ear and labyrinth disorders           
Vertigo * 1  2/26 (7.69%)  2/53 (3.77%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Tinnitus * 1  1/26 (3.85%)  0/53 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Eye disorders           
Noninfective Conjunctivitis * 1  2/26 (7.69%)  1/53 (1.89%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Periorbital Oedema * 1  2/26 (7.69%)  3/53 (5.66%)  2/13 (15.38%)  0/6 (0.00%)  1/14 (7.14%) 
Vision Blurred * 1  1/26 (3.85%)  3/53 (5.66%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Idiopathic Orbital Inflammation * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Visual Acuity Reduced * 1  0/26 (0.00%)  2/53 (3.77%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders           
Abdominal Distension * 1  2/26 (7.69%)  4/53 (7.55%)  1/13 (7.69%)  0/6 (0.00%)  3/14 (21.43%) 
Abdominal Pain * 1  2/26 (7.69%)  8/53 (15.09%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Abdominal Pain Upper * 1  2/26 (7.69%)  5/53 (9.43%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Aphthous Ulcer * 1  1/26 (3.85%)  4/53 (7.55%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Ascites * 1  3/26 (11.54%)  3/53 (5.66%)  1/13 (7.69%)  1/6 (16.67%)  2/14 (14.29%) 
Constipation * 1  2/26 (7.69%)  6/53 (11.32%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Diarrhoea * 1  8/26 (30.77%)  13/53 (24.53%)  4/13 (30.77%)  2/6 (33.33%)  3/14 (21.43%) 
Dyspepsia * 1  4/26 (15.38%)  2/53 (3.77%)  3/13 (23.08%)  0/6 (0.00%)  1/14 (7.14%) 
Gastrooesophageal Reflux Disease * 1  0/26 (0.00%)  4/53 (7.55%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Nausea * 1  7/26 (26.92%)  5/53 (9.43%)  3/13 (23.08%)  1/6 (16.67%)  0/14 (0.00%) 
Tongue Ulceration * 1  2/26 (7.69%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Vomiting * 1  5/26 (19.23%)  6/53 (11.32%)  3/13 (23.08%)  0/6 (0.00%)  2/14 (14.29%) 
Abdominal Discomfort * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Abdominal Pain Lower * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Haemorrhoidal Haemorrhage * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Ileus Paralytic * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Oesophagitis * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Tongue Coated * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Upper Gastrointestinal Haemorrhage * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
General disorders           
Chest Pain * 1  2/26 (7.69%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Face Oedema * 1  1/26 (3.85%)  6/53 (11.32%)  1/13 (7.69%)  1/6 (16.67%)  1/14 (7.14%) 
Fatigue * 1  14/26 (53.85%)  18/53 (33.96%)  8/13 (61.54%)  2/6 (33.33%)  4/14 (28.57%) 
Generalised Oedema * 1  4/26 (15.38%)  7/53 (13.21%)  2/13 (15.38%)  2/6 (33.33%)  1/14 (7.14%) 
Localised Oedema * 1  3/26 (11.54%)  11/53 (20.75%)  2/13 (15.38%)  2/6 (33.33%)  1/14 (7.14%) 
Malaise * 1  7/26 (26.92%)  15/53 (28.30%)  6/13 (46.15%)  2/6 (33.33%)  5/14 (35.71%) 
Oedema Peripheral * 1  8/26 (30.77%)  19/53 (35.85%)  4/13 (30.77%)  3/6 (50.00%)  5/14 (35.71%) 
Pain * 1  2/26 (7.69%)  3/53 (5.66%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Pyrexia * 1  4/26 (15.38%)  6/53 (11.32%)  2/13 (15.38%)  0/6 (0.00%)  3/14 (21.43%) 
Chest Discomfort * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Chills * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Influenza Like Illness * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Infusion Site Extravasation * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Hepatobiliary disorders           
Hepatic Function Abnormal * 1  3/26 (11.54%)  2/53 (3.77%)  3/13 (23.08%)  0/6 (0.00%)  0/14 (0.00%) 
Immune system disorders           
Seasonal Allergy * 1  1/26 (3.85%)  2/53 (3.77%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Infections and infestations           
Folliculitis * 1  2/26 (7.69%)  1/53 (1.89%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Gastroenteritis * 1  3/26 (11.54%)  4/53 (7.55%)  1/13 (7.69%)  0/6 (0.00%)  2/14 (14.29%) 
Nasopharyngitis * 1  1/26 (3.85%)  9/53 (16.98%)  1/13 (7.69%)  1/6 (16.67%)  2/14 (14.29%) 
Rash Pustular * 1  2/26 (7.69%)  4/53 (7.55%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Upper Respiratory Tract Infection * 1  6/26 (23.08%)  20/53 (37.74%)  4/13 (30.77%)  1/6 (16.67%)  2/14 (14.29%) 
Urinary Tract Infection * 1  0/26 (0.00%)  4/53 (7.55%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Bronchitis * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Herpes Virus Infection * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Herpes Zoster * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Lower Respiratory Tract Infection * 1  0/26 (0.00%)  2/53 (3.77%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Oral Candidiasis * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Pharyngitis * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Pneumonia * 1  0/26 (0.00%)  2/53 (3.77%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Respiratory Tract Infection * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Skin Infection * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Tonsillitis * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Viral Infection * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Injury, poisoning and procedural complications           
Ligament Sprain * 1  2/26 (7.69%)  0/53 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Arthropod Bite * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Contusion * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Head Injury * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Post-Traumatic Pain * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Procedural Nausea * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Road Traffic Accident * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Skin Abrasion * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Wound * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Wound Complication * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Investigations           
Blood Albumin Decreased * 1  3/26 (11.54%)  1/53 (1.89%)  2/13 (15.38%)  1/6 (16.67%)  1/14 (7.14%) 
Serum Ferritin Decreased * 1  0/26 (0.00%)  3/53 (5.66%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Weight Decreased * 1  7/26 (26.92%)  4/53 (7.55%)  3/13 (23.08%)  3/6 (50.00%)  2/14 (14.29%) 
Weight Increased * 1  0/26 (0.00%)  11/53 (20.75%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Blood Creatine Phosphokinase Increased * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Blood Folate Decreased * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Blood Iron Decreased * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Blood Phosphorus Increased * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Haemoglobin Increased * 1  0/26 (0.00%)  2/53 (3.77%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Iron Binding Capacity Total Decreased * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Iron Binding Capacity Unsaturated Decreased * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Platelet Count Increased * 1  1/26 (3.85%)  0/53 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Protein Total Decreased * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Protein Total Increased * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Protein Urine Present * 1  1/26 (3.85%)  0/53 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Reticulocyte Count Decreased * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Reticulocyte Percentage Decreased * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Vitamin B12 Decreased * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders           
Decreased Appetite * 1  7/26 (26.92%)  9/53 (16.98%)  4/13 (30.77%)  3/6 (50.00%)  4/14 (28.57%) 
Enzyme Abnormality * 1  4/26 (15.38%)  1/53 (1.89%)  4/13 (30.77%)  1/6 (16.67%)  0/14 (0.00%) 
Hypercholesterolaemia * 1  0/26 (0.00%)  3/53 (5.66%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Hyperglycaemia * 1  2/26 (7.69%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Hyperkalaemia * 1  0/26 (0.00%)  3/53 (5.66%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Hypertriglyceridaemia * 1  2/26 (7.69%)  7/53 (13.21%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Hyperuricaemia * 1  1/26 (3.85%)  7/53 (13.21%)  1/13 (7.69%)  1/6 (16.67%)  3/14 (21.43%) 
Hypoalbuminaemia * 1  2/26 (7.69%)  2/53 (3.77%)  1/13 (7.69%)  2/6 (33.33%)  1/14 (7.14%) 
Hypocalcaemia * 1  4/26 (15.38%)  3/53 (5.66%)  2/13 (15.38%)  1/6 (16.67%)  3/14 (21.43%) 
Hypoglycaemia * 1  2/26 (7.69%)  1/53 (1.89%)  0/13 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Hypokalaemia * 1  3/26 (11.54%)  6/53 (11.32%)  1/13 (7.69%)  1/6 (16.67%)  1/14 (7.14%) 
Fluid Overload * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Gout * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Hyperphosphataemia * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Hypocholesterolaemia * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Hyponatraemia * 1  1/26 (3.85%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  5/26 (19.23%)  4/53 (7.55%)  4/13 (30.77%)  1/6 (16.67%)  1/14 (7.14%) 
Back Pain * 1  6/26 (23.08%)  4/53 (7.55%)  4/13 (30.77%)  1/6 (16.67%)  1/14 (7.14%) 
Muscle Spasms * 1  2/26 (7.69%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Muscular Weakness * 1  0/26 (0.00%)  3/53 (5.66%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Musculoskeletal Pain * 1  2/26 (7.69%)  3/53 (5.66%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Myalgia * 1  3/26 (11.54%)  2/53 (3.77%)  3/13 (23.08%)  1/6 (16.67%)  0/14 (0.00%) 
Pain in Extremity * 1  2/26 (7.69%)  1/53 (1.89%)  2/13 (15.38%)  1/6 (16.67%)  0/14 (0.00%) 
Arthritis * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Chondropathy * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Joint Stiffness * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Synovitis * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Tumour Pain * 1  4/26 (15.38%)  4/53 (7.55%)  2/13 (15.38%)  0/6 (0.00%)  1/14 (7.14%) 
Nervous system disorders           
Dizziness * 1  2/26 (7.69%)  6/53 (11.32%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Headache * 1  1/26 (3.85%)  6/53 (11.32%)  0/13 (0.00%)  0/6 (0.00%)  2/14 (14.29%) 
Peripheral Motor Neuropathy * 1  4/26 (15.38%)  6/53 (11.32%)  2/13 (15.38%)  2/6 (33.33%)  1/14 (7.14%) 
Peripheral Sensory Neuropathy * 1  7/26 (26.92%)  13/53 (24.53%)  5/13 (38.46%)  3/6 (50.00%)  3/14 (21.43%) 
Somnolence * 1  1/26 (3.85%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Syncope * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Psychiatric disorders           
Insomnia * 1  2/26 (7.69%)  5/53 (9.43%)  0/13 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Renal and urinary disorders           
Azotaemia * 1  2/26 (7.69%)  2/53 (3.77%)  1/13 (7.69%)  1/6 (16.67%)  1/14 (7.14%) 
Pollakiuria * 1  2/26 (7.69%)  1/53 (1.89%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Renal Impairment * 1  2/26 (7.69%)  4/53 (7.55%)  2/13 (15.38%)  1/6 (16.67%)  2/14 (14.29%) 
Haematuria * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Polyuria * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Proteinuria * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Reproductive system and breast disorders           
Oedema Genital * 1  2/26 (7.69%)  3/53 (5.66%)  0/13 (0.00%)  1/6 (16.67%)  2/14 (14.29%) 
Benign Prostatic Hyperplasia * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Pelvic Pain * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Scrotal Swelling * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough * 1  8/26 (30.77%)  8/53 (15.09%)  3/13 (23.08%)  1/6 (16.67%)  0/14 (0.00%) 
Dyspnoea * 1  9/26 (34.62%)  13/53 (24.53%)  4/13 (30.77%)  0/6 (0.00%)  3/14 (21.43%) 
Oropharyngeal Pain * 1  2/26 (7.69%)  4/53 (7.55%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Pleural Effusion * 1  5/26 (19.23%)  2/53 (3.77%)  2/13 (15.38%)  3/6 (50.00%)  2/14 (14.29%) 
Epistaxis * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  1/6 (16.67%)  0/14 (0.00%) 
Nasal Inflammation * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Productive Cough * 1  1/26 (3.85%)  2/53 (3.77%)  0/13 (0.00%)  1/6 (16.67%)  0/14 (0.00%) 
Wheezing * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis Acneiform * 1  2/26 (7.69%)  4/53 (7.55%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Dry Skin * 1  0/26 (0.00%)  4/53 (7.55%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Eczema * 1  1/26 (3.85%)  5/53 (9.43%)  1/13 (7.69%)  0/6 (0.00%)  1/14 (7.14%) 
Erythema * 1  2/26 (7.69%)  2/53 (3.77%)  2/13 (15.38%)  0/6 (0.00%)  1/14 (7.14%) 
Hyperhidrosis * 1  7/26 (26.92%)  10/53 (18.87%)  5/13 (38.46%)  2/6 (33.33%)  2/14 (14.29%) 
Night Sweats * 1  4/26 (15.38%)  9/53 (16.98%)  4/13 (30.77%)  1/6 (16.67%)  4/14 (28.57%) 
Pruritus * 1  6/26 (23.08%)  22/53 (41.51%)  4/13 (30.77%)  2/6 (33.33%)  3/14 (21.43%) 
Rash * 1  1/26 (3.85%)  7/53 (13.21%)  0/13 (0.00%)  0/6 (0.00%)  0/14 (0.00%) 
Rash Maculo-Papular * 1  5/26 (19.23%)  18/53 (33.96%)  3/13 (23.08%)  2/6 (33.33%)  2/14 (14.29%) 
Skin Hyperpigmentation * 1  0/26 (0.00%)  5/53 (9.43%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Skin Induration * 1  2/26 (7.69%)  2/53 (3.77%)  1/13 (7.69%)  1/6 (16.67%)  1/14 (7.14%) 
Blister * 1  1/26 (3.85%)  1/53 (1.89%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Rash Pruritic * 1  1/26 (3.85%)  2/53 (3.77%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
Skin Ulcer * 1  0/26 (0.00%)  1/53 (1.89%)  0/13 (0.00%)  0/6 (0.00%)  1/14 (7.14%) 
Vascular disorders           
Flushing * 1  2/26 (7.69%)  2/53 (3.77%)  2/13 (15.38%)  0/6 (0.00%)  0/14 (0.00%) 
Hypertension * 1  3/26 (11.54%)  4/53 (7.55%)  3/13 (23.08%)  0/6 (0.00%)  1/14 (7.14%) 
Haemorrhage * 1  1/26 (3.85%)  0/53 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  0/14 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: DIRECTOR CLINICAL RESEARCH
Organization: Janssen R&D US
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01024036     History of Changes
Other Study ID Numbers: CR016705
CNTO328MCD2001 ( Other Identifier: Janssen Research & Development, LLC )
2009-012380-34 ( EudraCT Number )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: May 16, 2014
Results First Posted: August 20, 2014
Last Update Posted: March 21, 2018