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An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

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ClinicalTrials.gov Identifier: NCT01985126
Recruitment Status : Completed
First Posted : November 15, 2013
Results First Posted : February 2, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Daratumumab 16 mg/kg (Part 1)
Drug: Daratumumab 8 mg/kg (Part 1)
Drug: Methylprednisolone
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Daratumumab (Part 2)
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity. Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 18 106
Completed 0 0
Not Completed 18 106
Reason Not Completed
Death             15             69
Lost to Follow-up             0             8
Study Terminated By Sponsor             1             22
Withdrawal by Subject             2             7
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg Total
Hide Arm/Group Description Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity. Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 18 106 124
Hide Baseline Analysis Population Description
All treated Analysis Set included all participants who received at least 1 dose of daratumumab.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 106 participants 124 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  44.4%
58
  54.7%
66
  53.2%
>=65 years
10
  55.6%
48
  45.3%
58
  46.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 106 participants 124 participants
64.2  (7.72) 62.9  (10) 63.1  (9.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 106 participants 124 participants
Female
6
  33.3%
54
  50.9%
60
  48.4%
Male
12
  66.7%
52
  49.1%
64
  51.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 18 participants 106 participants 124 participants
Canada
0
   0.0%
22
  20.8%
22
  17.7%
Spain
3
  16.7%
9
   8.5%
12
   9.7%
United States
15
  83.3%
75
  70.8%
90
  72.6%
Stage of Disease (ISS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 106 participants 124 participants
I
2
  11.1%
26
  24.5%
28
  22.6%
II
8
  44.4%
40
  37.7%
48
  38.7%
III
8
  44.4%
40
  37.7%
48
  38.7%
[1]
Measure Description: The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (>=) 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin >= 5.5 mg/l.
Number of Prior Lines of Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 106 participants 124 participants
<= 3 Lines
6
  33.3%
19
  17.9%
25
  20.2%
> 3 Lines
12
  66.7%
87
  82.1%
99
  79.8%
Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory Drug (IMiD)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 106 participants 124 participants
Both a PI and IMiD
15
  83.3%
101
  95.3%
116
  93.5%
PI only
1
   5.6%
3
   2.8%
4
   3.2%
IMiD only
0
   0.0%
1
   0.9%
1
   0.8%
None
2
  11.1%
1
   0.9%
3
   2.4%
1.Primary Outcome
Title Percentage of Participants With Overall Response
Hide Description Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; 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.
Time Frame Up to 14.4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who received at least 1 dose of daratumumab.
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description:
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.1
(1.4 to 34.7)
29.2
(20.8 to 38.9)
2.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder.
Time Frame Up to 14.4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Responders in all treated analysis set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description:
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 2 31
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(1.8 to NA)
7.4 [1] 
(5.5 to NA)
[1]
These were Kaplan-Meier estimates. Median and/or upper limit of CI was not estimable because a small proportion of responders either progressed or died due to progressive disease.
3.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Time Frame Approximately up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who received at least 1 dose of daratumumab.
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description:
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18 106
Median (95% Confidence Interval)
Unit of Measure: months
19.45
(7.72 to 26.81)
18.60
(13.67 to 25.00)
4.Secondary Outcome
Title Percentage of Participants With Clinical Benefit
Hide Description Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas.
Time Frame Up to 14.4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who received at least 1 dose of daratumumab.
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description:
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.2
(6.4 to 47.6)
34.0
(25.0 to 43.8)
5.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better).
Time Frame Up to 14.4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Responders in all treated analysis set. Only those participants with confirmed PR were analyzed.
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description:
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 2 31
Median (Full Range)
Unit of Measure: months
0.99
(0.95 to 1.02)
0.99
(0.9 to 5.6)
6.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.
Time Frame Up to 14.4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who received at least 1 dose of daratumumab.
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description:
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18 106
Median (95% Confidence Interval)
Unit of Measure: months
4.86 [1] 
(1.84 to NA)
3.65
(2.76 to 4.63)
[1]
Upper limit of CI was not estimable due to the relatively short duration of follow-up.
7.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression.
Time Frame Up to 14.4 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who received at least 1 dose of daratumumab.
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description:
Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18 106
Median (95% Confidence Interval)
Unit of Measure: months
4.86 [1] 
(1.84 to NA)
3.71
(2.79 to 5.39)
[1]
Upper limit of CI was not estimable due to the relatively short duration of follow-up.
Time Frame Approximately up to 3.8 years
Adverse Event Reporting Description All treated Analysis Set included all participants who received at least 1 dose of daratumumab.
 
Arm/Group Title Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Hide Arm/Group Description Daratumumab 8 milligram per kilogram (mg/kg) every 4 weeks (Q4W) until disease progression or unacceptable toxicity. Daratumumab 16 mg/kg weekly for 8 weeks; then every 2 weeks (Q2W) for 16 weeks; then Q4W until disease progression or unacceptable toxicity.
All-Cause Mortality
Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   6/18 (33.33%)   33/106 (31.13%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/18 (0.00%)  2/106 (1.89%) 
Thrombocytopenia * 1  0/18 (0.00%)  1/106 (0.94%) 
Cardiac disorders     
Cardiac Failure Congestive * 1  0/18 (0.00%)  1/106 (0.94%) 
Cardio-Respiratory Arrest * 1  0/18 (0.00%)  1/106 (0.94%) 
Gastrointestinal disorders     
Abdominal Pain * 1  0/18 (0.00%)  1/106 (0.94%) 
Faecal Incontinence * 1  0/18 (0.00%)  1/106 (0.94%) 
Large Intestinal Obstruction * 1  0/18 (0.00%)  1/106 (0.94%) 
Nausea * 1  1/18 (5.56%)  0/106 (0.00%) 
Pancreatitis * 1  0/18 (0.00%)  1/106 (0.94%) 
Vomiting * 1  1/18 (5.56%)  0/106 (0.00%) 
General disorders     
Asthenia * 1  0/18 (0.00%)  1/106 (0.94%) 
Fatigue * 1  0/18 (0.00%)  1/106 (0.94%) 
General Physical Health Deterioration * 1  1/18 (5.56%)  5/106 (4.72%) 
Pyrexia * 1  0/18 (0.00%)  1/106 (0.94%) 
Hepatobiliary disorders     
Hepatic Failure * 1  0/18 (0.00%)  1/106 (0.94%) 
Infections and infestations     
Bronchitis * 1  0/18 (0.00%)  1/106 (0.94%) 
H1n1 Influenza * 1  0/18 (0.00%)  1/106 (0.94%) 
Herpes Zoster * 1  0/18 (0.00%)  1/106 (0.94%) 
Lobar Pneumonia * 1  0/18 (0.00%)  2/106 (1.89%) 
Parainfluenzae Virus Infection * 1  0/18 (0.00%)  1/106 (0.94%) 
Pneumonia * 1  0/18 (0.00%)  4/106 (3.77%) 
Pneumonia Streptococcal * 1  0/18 (0.00%)  1/106 (0.94%) 
Pyelonephritis * 1  0/18 (0.00%)  1/106 (0.94%) 
Respiratory Tract Infection * 1  0/18 (0.00%)  1/106 (0.94%) 
Sepsis * 1  0/18 (0.00%)  1/106 (0.94%) 
Soft Tissue Infection * 1  0/18 (0.00%)  1/106 (0.94%) 
Upper Respiratory Tract Infection * 1  0/18 (0.00%)  1/106 (0.94%) 
Varicella * 1  0/18 (0.00%)  1/106 (0.94%) 
Injury, poisoning and procedural complications     
Spinal Compression Fracture * 1  0/18 (0.00%)  1/106 (0.94%) 
Subdural Haematoma * 1  0/18 (0.00%)  1/106 (0.94%) 
Investigations     
Blood Creatinine Increased * 1  0/18 (0.00%)  1/106 (0.94%) 
Oxygen Saturation Abnormal * 1  0/18 (0.00%)  1/106 (0.94%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  0/18 (0.00%)  4/106 (3.77%) 
Hyperkalaemia * 1  0/18 (0.00%)  1/106 (0.94%) 
Hyperuricaemia * 1  1/18 (5.56%)  0/106 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  1/18 (5.56%)  1/106 (0.94%) 
Musculoskeletal Chest Pain * 1  0/18 (0.00%)  2/106 (1.89%) 
Pathological Fracture * 1  0/18 (0.00%)  1/106 (0.94%) 
Spinal Column Stenosis * 1  0/18 (0.00%)  1/106 (0.94%) 
Spinal Pain * 1  0/18 (0.00%)  1/106 (0.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Plasma Cell Leukaemia * 1  1/18 (5.56%)  0/106 (0.00%) 
Nervous system disorders     
Headache * 1  0/18 (0.00%)  1/106 (0.94%) 
Spinal Cord Compression * 1  0/18 (0.00%)  1/106 (0.94%) 
Syncope * 1  1/18 (5.56%)  0/106 (0.00%) 
Tremor * 1  0/18 (0.00%)  1/106 (0.94%) 
Psychiatric disorders     
Delirium * 1  0/18 (0.00%)  1/106 (0.94%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  1/18 (5.56%)  0/106 (0.00%) 
Haematuria * 1  0/18 (0.00%)  1/106 (0.94%) 
Renal Impairment * 1  1/18 (5.56%)  0/106 (0.00%) 
Urinary Retention * 1  1/18 (5.56%)  0/106 (0.00%) 
Urinary Tract Obstruction * 1  0/18 (0.00%)  1/106 (0.94%) 
Reproductive system and breast disorders     
Pelvic Pain * 1  1/18 (5.56%)  0/106 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  0/18 (0.00%)  1/106 (0.94%) 
Pleural Effusion * 1  1/18 (5.56%)  1/106 (0.94%) 
Pneumonia Aspiration * 1  0/18 (0.00%)  1/106 (0.94%) 
Respiratory Failure * 1  0/18 (0.00%)  1/106 (0.94%) 
Vascular disorders     
Deep Vein Thrombosis * 1  0/18 (0.00%)  1/106 (0.94%) 
Hypotension * 1  0/18 (0.00%)  1/106 (0.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daratumumab 8 mg/kg Daratumumab 16 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   18/18 (100.00%)   105/106 (99.06%) 
Blood and lymphatic system disorders     
Anaemia * 1  9/18 (50.00%)  39/106 (36.79%) 
Leukopenia * 1  2/18 (11.11%)  8/106 (7.55%) 
Lymphopenia * 1  3/18 (16.67%)  5/106 (4.72%) 
Neutropenia * 1  2/18 (11.11%)  26/106 (24.53%) 
Thrombocytopenia * 1  6/18 (33.33%)  28/106 (26.42%) 
Cardiac disorders     
Sinus Tachycardia * 1  1/18 (5.56%)  1/106 (0.94%) 
Tachycardia * 1  1/18 (5.56%)  3/106 (2.83%) 
Ear and labyrinth disorders     
Cerumen Impaction * 1  1/18 (5.56%)  0/106 (0.00%) 
Ear Discomfort * 1  1/18 (5.56%)  0/106 (0.00%) 
Eye disorders     
Cataract * 1  1/18 (5.56%)  1/106 (0.94%) 
Gastrointestinal disorders     
Abdominal Discomfort * 1  1/18 (5.56%)  3/106 (2.83%) 
Abdominal Distension * 1  1/18 (5.56%)  3/106 (2.83%) 
Abdominal Pain * 1  1/18 (5.56%)  7/106 (6.60%) 
Aphthous Stomatitis * 1  1/18 (5.56%)  0/106 (0.00%) 
Constipation * 1  1/18 (5.56%)  19/106 (17.92%) 
Diarrhoea * 1  4/18 (22.22%)  22/106 (20.75%) 
Dry Mouth * 1  1/18 (5.56%)  0/106 (0.00%) 
Gastritis * 1  1/18 (5.56%)  0/106 (0.00%) 
Nausea * 1  4/18 (22.22%)  34/106 (32.08%) 
Vomiting * 1  2/18 (11.11%)  19/106 (17.92%) 
General disorders     
Asthenia * 1  2/18 (11.11%)  12/106 (11.32%) 
Chest Discomfort * 1  1/18 (5.56%)  3/106 (2.83%) 
Chills * 1  6/18 (33.33%)  10/106 (9.43%) 
Fatigue * 1  6/18 (33.33%)  42/106 (39.62%) 
Non-Cardiac Chest Pain * 1  1/18 (5.56%)  6/106 (5.66%) 
Oedema * 1  1/18 (5.56%)  2/106 (1.89%) 
Oedema Peripheral * 1  2/18 (11.11%)  9/106 (8.49%) 
Pain * 1  1/18 (5.56%)  6/106 (5.66%) 
Pyrexia * 1  5/18 (27.78%)  20/106 (18.87%) 
Hepatobiliary disorders     
Hepatic Steatosis * 1  1/18 (5.56%)  0/106 (0.00%) 
Immune system disorders     
Cytokine Release Syndrome * 1  1/18 (5.56%)  0/106 (0.00%) 
Infections and infestations     
Bronchitis * 1  0/18 (0.00%)  7/106 (6.60%) 
Candida Infection * 1  1/18 (5.56%)  1/106 (0.94%) 
Influenza * 1  2/18 (11.11%)  4/106 (3.77%) 
Nasopharyngitis * 1  1/18 (5.56%)  8/106 (7.55%) 
Pneumonia * 1  1/18 (5.56%)  4/106 (3.77%) 
Sinusitis * 1  1/18 (5.56%)  7/106 (6.60%) 
Upper Respiratory Tract Infection * 1  2/18 (11.11%)  21/106 (19.81%) 
Urinary Tract Infection * 1  0/18 (0.00%)  7/106 (6.60%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/18 (5.56%)  5/106 (4.72%) 
Investigations     
Aspartate Aminotransferase Increased * 1  1/18 (5.56%)  4/106 (3.77%) 
Blood Alkaline Phosphatase Increased * 1  3/18 (16.67%)  4/106 (3.77%) 
Blood Creatinine Increased * 1  7/18 (38.89%)  9/106 (8.49%) 
Blood Urea Increased * 1  1/18 (5.56%)  0/106 (0.00%) 
Gamma-Glutamyltransferase Increased * 1  1/18 (5.56%)  1/106 (0.94%) 
Transaminases Increased * 1  1/18 (5.56%)  0/106 (0.00%) 
Weight Decreased * 1  2/18 (11.11%)  5/106 (4.72%) 
Weight Increased * 1  1/18 (5.56%)  4/106 (3.77%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  4/18 (22.22%)  19/106 (17.92%) 
Fluid Retention * 1  1/18 (5.56%)  0/106 (0.00%) 
Hypercalcaemia * 1  2/18 (11.11%)  16/106 (15.09%) 
Hyperglycaemia * 1  3/18 (16.67%)  9/106 (8.49%) 
Hyperkalaemia * 1  1/18 (5.56%)  3/106 (2.83%) 
Hyperuricaemia * 1  1/18 (5.56%)  4/106 (3.77%) 
Hypoalbuminaemia * 1  4/18 (22.22%)  5/106 (4.72%) 
Hypocalcaemia * 1  1/18 (5.56%)  3/106 (2.83%) 
Hypoglycaemia * 1  1/18 (5.56%)  1/106 (0.94%) 
Hypokalaemia * 1  4/18 (22.22%)  11/106 (10.38%) 
Hypomagnesaemia * 1  2/18 (11.11%)  8/106 (7.55%) 
Hyponatraemia * 1  6/18 (33.33%)  7/106 (6.60%) 
Hypophosphataemia * 1  1/18 (5.56%)  0/106 (0.00%) 
Metabolic Acidosis * 1  1/18 (5.56%)  0/106 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/18 (11.11%)  20/106 (18.87%) 
Back Pain * 1  5/18 (27.78%)  25/106 (23.58%) 
Bone Pain * 1  0/18 (0.00%)  10/106 (9.43%) 
Flank Pain * 1  1/18 (5.56%)  0/106 (0.00%) 
Muscle Spasms * 1  2/18 (11.11%)  9/106 (8.49%) 
Musculoskeletal Chest Pain * 1  2/18 (11.11%)  15/106 (14.15%) 
Musculoskeletal Pain * 1  1/18 (5.56%)  12/106 (11.32%) 
Myalgia * 1  0/18 (0.00%)  6/106 (5.66%) 
Pain in Extremity * 1  1/18 (5.56%)  20/106 (18.87%) 
Nervous system disorders     
Anaesthesia * 1  1/18 (5.56%)  0/106 (0.00%) 
Dizziness * 1  1/18 (5.56%)  10/106 (9.43%) 
Dysgeusia * 1  2/18 (11.11%)  3/106 (2.83%) 
Encephalopathy * 1  1/18 (5.56%)  1/106 (0.94%) 
Headache * 1  2/18 (11.11%)  13/106 (12.26%) 
Hypoaesthesia * 1  1/18 (5.56%)  6/106 (5.66%) 
Peripheral Sensory Neuropathy * 1  1/18 (5.56%)  6/106 (5.66%) 
Sciatica * 1  1/18 (5.56%)  0/106 (0.00%) 
Tremor * 1  2/18 (11.11%)  2/106 (1.89%) 
Psychiatric disorders     
Anxiety * 1  0/18 (0.00%)  8/106 (7.55%) 
Confusional State * 1  1/18 (5.56%)  7/106 (6.60%) 
Depression * 1  1/18 (5.56%)  3/106 (2.83%) 
Mental Status Changes * 1  1/18 (5.56%)  1/106 (0.94%) 
Nervousness * 1  1/18 (5.56%)  0/106 (0.00%) 
Renal and urinary disorders     
Bladder Spasm * 1  1/18 (5.56%)  0/106 (0.00%) 
Haematuria * 1  2/18 (11.11%)  2/106 (1.89%) 
Micturition Urgency * 1  1/18 (5.56%)  0/106 (0.00%) 
Urinary Incontinence * 1  2/18 (11.11%)  1/106 (0.94%) 
Reproductive system and breast disorders     
Nipple Pain * 1  1/18 (5.56%)  1/106 (0.94%) 
Prostatitis * 1  1/18 (5.56%)  0/106 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  6/18 (33.33%)  27/106 (25.47%) 
Dyspnoea * 1  3/18 (16.67%)  18/106 (16.98%) 
Dyspnoea Exertional * 1  1/18 (5.56%)  9/106 (8.49%) 
Epistaxis * 1  0/18 (0.00%)  9/106 (8.49%) 
Nasal Congestion * 1  2/18 (11.11%)  22/106 (20.75%) 
Oropharyngeal Pain * 1  1/18 (5.56%)  9/106 (8.49%) 
Pleural Effusion * 1  1/18 (5.56%)  3/106 (2.83%) 
Productive Cough * 1  1/18 (5.56%)  8/106 (7.55%) 
Throat Irritation * 1  0/18 (0.00%)  7/106 (6.60%) 
Wheezing * 1  1/18 (5.56%)  7/106 (6.60%) 
Skin and subcutaneous tissue disorders     
Actinic Keratosis * 1  1/18 (5.56%)  0/106 (0.00%) 
Nail Discolouration * 1  1/18 (5.56%)  0/106 (0.00%) 
Pruritus * 1  1/18 (5.56%)  3/106 (2.83%) 
Rash * 1  1/18 (5.56%)  2/106 (1.89%) 
Rash Macular * 1  1/18 (5.56%)  1/106 (0.94%) 
Urticaria * 1  1/18 (5.56%)  1/106 (0.94%) 
Vascular disorders     
Deep Vein Thrombosis * 1  1/18 (5.56%)  1/106 (0.94%) 
Hypertension * 1  8/18 (44.44%)  12/106 (11.32%) 
Hypotension * 1  2/18 (11.11%)  6/106 (5.66%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
[Not Specified]
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.
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 in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Leader
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01985126    
Other Study ID Numbers: CR102651
54767414MMY2002 ( Other Identifier: Janssen Research & Development, LLC )
2013-000752-18 ( EudraCT Number )
First Submitted: July 22, 2013
First Posted: November 15, 2013
Results First Submitted: September 30, 2016
Results First Posted: February 2, 2017
Last Update Posted: June 25, 2018