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Trial record 35 of 179 for:    LENALIDOMIDE AND Leukemia

Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00963105
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : October 2, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsed or Refractory Chronic Lymphocytic Leukemia
Intervention Drug: lenalidomide
Enrollment 104
Recruitment Details Participants were randomized at 29 sites from North America and Europe.
Pre-assignment Details Participants were randomized (1:1:1) in a double-blind fashion, according to age (< 65 versus ≥ 65 years) and disease status (relapsed versus refractory) to their last purine-analog or bendamustine-based prior regimen.
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
Period Title: Overall Study
Started 34 35 35
Received Treatment 34 34 35
Completed [1] 34 35 35
Not Completed 0 0 0
[1]
completed represents participants who discontinued the study.
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg Total
Hide Arm/Group Description Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Total of all reporting groups
Overall Number of Baseline Participants 34 35 35 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 35 participants 35 participants 104 participants
64.0  (9.46) 63.3  (8.31) 63.7  (7.56) 63.6  (8.39)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 35 participants 104 participants
< 65 years
16
  47.1%
19
  54.3%
17
  48.6%
52
  50.0%
≥ 65 years
18
  52.9%
16
  45.7%
18
  51.4%
52
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 35 participants 104 participants
Female
8
  23.5%
13
  37.1%
11
  31.4%
32
  30.8%
Male
26
  76.5%
22
  62.9%
24
  68.6%
72
  69.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 35 participants 104 participants
White
31
  91.2%
30
  85.7%
33
  94.3%
94
  90.4%
Black or African American
2
   5.9%
4
  11.4%
2
   5.7%
8
   7.7%
Other
0
   0.0%
1
   2.9%
0
   0.0%
1
   1.0%
Unknown
1
   2.9%
0
   0.0%
0
   0.0%
1
   1.0%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events
Hide Description Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the observed event.
Time Frame From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least one dose of study drug.
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 34 34 35
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse events
34
 100.0%
34
 100.0%
35
 100.0%
Treatment-related adverse events (TRAE)
33
  97.1%
34
 100.0%
32
  91.4%
Grade 3/4 adverse events
33
  97.1%
32
  94.1%
34
  97.1%
Treatment-related Grade 3/4 adverse events
31
  91.2%
32
  94.1%
30
  85.7%
Grade 5 adverse events
4
  11.8%
4
  11.8%
3
   8.6%
Treatment-related Grade 5 adverse events
2
   5.9%
2
   5.9%
0
   0.0%
Serious adverse events
24
  70.6%
24
  70.6%
27
  77.1%
Treatment-related serious adverse events
15
  44.1%
13
  38.2%
20
  57.1%
AE leading to discontinuation of study drug
21
  61.8%
17
  50.0%
16
  45.7%
TRAE leading to discontinuation of study drug
16
  47.1%
14
  41.2%
13
  37.1%
AE leading to study drug dose reduction only
8
  23.5%
6
  17.6%
5
  14.3%
AE leading to study drug dose interruption only
25
  73.5%
24
  70.6%
25
  71.4%
AE leading to study drug interruption & reduction
18
  52.9%
26
  76.5%
19
  54.3%
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/L, hemoglobin (hgb) >11g/dL) and BM at least normocellular for age. CRi = CR with incomplete BM recovery. PR = required at least 2 months from end of treatment, a ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value and either a ≥ 50% reduction in lymphadenopathy or ≥50% reduction of liver enlargement or ≥50% reduction of spleen enlargement plus neutrophils >1.5 x 10^9/ or ≥50% increase, platelets >100 x 10^9/L or ≥50% increase, hgb 11 g/dL.
Time Frame Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants (intent-to-treat population)
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 34 35 35
Measure Type: Number
Unit of Measure: percentage of participants
47.1 37.1 40.0
3.Secondary Outcome
Title Kaplan-Meier Estimate of Duration of Response
Hide Description Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.
Time Frame Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with an objective response (CR/CRi or PR)
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 16 13 14
Median (95% Confidence Interval)
Unit of Measure: weeks
101.1
(60.6 to 239.3)
35.1 [1] 
(22.0 to NA)
88.8
(72.1 to 127.3)
[1]
Could not be calculated due to the low number of events
4.Secondary Outcome
Title Time to Response
Hide Description Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period.
Time Frame Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with an objective response (CR/CRi or PR)
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 16 13 14
Median (Full Range)
Unit of Measure: weeks
16.9
(12.1 to 74.1)
12.6
(8.4 to 52.1)
12.7
(12.0 to 147.3)
5.Secondary Outcome
Title Kaplan-Meier Estimate of Time to Progression
Hide Description Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression.
Time Frame From randomization until the end of the study; maximum time on study was 91 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 34 35 35
Median (95% Confidence Interval)
Unit of Measure: weeks
96.3
(20.6 to 251.3)
47.6
(31.9 to 261.1)
66.3
(20.1 to 89.3)
6.Secondary Outcome
Title Kaplan-Meier Estimate of Event-Free Survival
Hide Description Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
Time Frame From randomization until the end of the study; maximum time on study was 91 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 34 35 35
Median (95% Confidence Interval)
Unit of Measure: weeks
25.6
(16.1 to 77.6)
31.9
(21.1 to 47.6)
24.1
(13.4 to 66.3)
7.Secondary Outcome
Title Kaplan-Meier Estimate of Progression Free Survival
Hide Description Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.
Time Frame From randomization until the end of the study; maximum time on study was 91 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 34 35 35
Median (95% Confidence Interval)
Unit of Measure: weeks
31.4
(16.1 to 96.3)
45.1
(22.4 to 120.1)
66.3
(16.1 to 89.3)
8.Secondary Outcome
Title Kaplan-Meier Estimate of Overall Survival
Hide Description Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who had withdrawn consent or were lost to follow-up before death was documented.
Time Frame From randomization until the end of the study; maximum time on study was 91 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description:
Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability.
Overall Number of Participants Analyzed 34 35 35
Median (95% Confidence Interval)
Unit of Measure: weeks
161.0
(64.9 to 209.0)
106.7
(83.4 to 235.7)
154.6
(80.9 to 214.7)
Time Frame From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Hide Arm/Group Description Participants received a starting dose of 5 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. Participants received a starting dose of 10 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug. Participants received a starting dose of 15 mg lenalidomide orally once a day. Lenalidomide dose was escalated by 5 mg in a step-wise manner every 28 days up to a maximum dose of 25 mg daily based on tolerability. Participants continued receiving study drug until disease progression or unacceptable toxicity, unless they withdrew consent or had other reasons to discontinue from study drug.
All-Cause Mortality
Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/34 (70.59%)   23/34 (67.65%)   26/35 (74.29%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/34 (70.59%)   24/34 (70.59%)   27/35 (77.14%) 
Blood and lymphatic system disorders       
AGRANULOCYTOSIS  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
ANAEMIA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
FEBRILE BONE MARROW APLASIA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
FEBRILE NEUTROPENIA  1  2/34 (5.88%)  4/34 (11.76%)  4/35 (11.43%) 
IMMUNE THROMBOCYTOPENIC PURPURA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
LYMPHADENITIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
NEUTROPENIA  1  1/34 (2.94%)  2/34 (5.88%)  3/35 (8.57%) 
SPLENIC INFARCTION  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
THROMBOCYTOPENIA  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
Cardiac disorders       
ARRHYTHMIA  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
CARDIAC TAMPONADE  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
MYOCARDIAL INFARCTION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
PERICARDIAL EFFUSION  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
SUPRAVENTRICULAR TACHYCARDIA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL HERNIA  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
ABDOMINAL PAIN  1  0/34 (0.00%)  3/34 (8.82%)  0/35 (0.00%) 
COLITIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
DIARRHOEA  1  1/34 (2.94%)  1/34 (2.94%)  1/35 (2.86%) 
INTESTINAL OBSTRUCTION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
PANCREATITIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
PANCREATITIS ACUTE  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
RECTAL HAEMORRHAGE  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
VOMITING  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
General disorders       
ASTHENIA  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
DEATH  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
DISEASE PROGRESSION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%) 
IMPAIRED HEALING  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
PAIN  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
PYREXIA  1  2/34 (5.88%)  1/34 (2.94%)  2/35 (5.71%) 
Hepatobiliary disorders       
CHOLECYSTITIS ACUTE  1  1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
Infections and infestations       
ASPERGILLUS INFECTION  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
ATYPICAL PNEUMONIA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
BACTERAEMIA  1  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
BRONCHOPULMONARY ASPERGILLOSIS  1  0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%) 
CELLULITIS  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  1/34 (2.94%)  0/34 (0.00%)  1/35 (2.86%) 
CLOSTRIDIUM DIFFICILE INFECTION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
DIVERTICULITIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
EPIDIDYMITIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
EPIGLOTTITIS  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
ESCHERICHIA BACTERAEMIA  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
ESCHERICHIA SEPSIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
ESCHERICHIA URINARY TRACT INFECTION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
GASTROENTERITIS  1  1/34 (2.94%)  0/34 (0.00%)  1/35 (2.86%) 
GASTROENTERITIS SALMONELLA  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
HERPES ZOSTER  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
INFECTIOUS MONONUCLEOSIS  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
LUNG INFECTION  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
NEUTROPENIC INFECTION  1  1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
OESOPHAGEAL CANDIDIASIS  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
ORAL CANDIDIASIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
PNEUMOCYSTIS JIROVECII PNEUMONIA  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
PNEUMONIA  1  5/34 (14.71%)  4/34 (11.76%)  10/35 (28.57%) 
PNEUMONIA INFLUENZAL  1  1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
POST PROCEDURAL CELLULITIS  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
RESPIRATORY TRACT INFECTION  1  1/34 (2.94%)  1/34 (2.94%)  2/35 (5.71%) 
SALMONELLOSIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
SEPSIS  1  1/34 (2.94%)  1/34 (2.94%)  1/35 (2.86%) 
SEPTIC SHOCK  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
SOFT TISSUE INFECTION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
STAPHYLOCOCCAL INFECTION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
SYSTEMIC MYCOSIS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
TUBERCULOSIS OF PERIPHERAL LYMPH NODES  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
URINARY TRACT INFECTION  1  0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%) 
WOUND INFECTION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Injury, poisoning and procedural complications       
ALCOHOL POISONING  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
FALL  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Metabolism and nutrition disorders       
DEHYDRATION  1  0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%) 
HYPERCALCAEMIA  1  3/34 (8.82%)  0/34 (0.00%)  2/35 (5.71%) 
HYPERKALAEMIA  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
TUMOUR LYSIS SYNDROME  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders       
ARTHRITIS REACTIVE  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
BACK PAIN  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
COCCYDYNIA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
GROIN PAIN  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ACUTE LYMPHOCYTIC LEUKAEMIA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
ADENOCARCINOMA  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
ADENOCARCINOMA PANCREAS  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
ANAL SQUAMOUS CELL CARCINOMA  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
BASAL CELL CARCINOMA  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
BOWEN'S DISEASE  1  1/34 (2.94%)  0/34 (0.00%)  1/35 (2.86%) 
KERATOACANTHOMA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
LUNG ADENOCARCINOMA  1  1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
MALIGNANT PLEURAL EFFUSION  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
MENINGIOMA BENIGN  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
METASTATIC SQUAMOUS CELL CARCINOMA  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
NEUROFIBROMA  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
OLIGOASTROCYTOMA  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  2/34 (5.88%)  1/34 (2.94%)  1/35 (2.86%) 
TUMOUR FLARE  1  2/34 (5.88%)  0/34 (0.00%)  6/35 (17.14%) 
Nervous system disorders       
CEREBRAL ISCHAEMIA  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
DIZZINESS  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
SYNCOPE  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Renal and urinary disorders       
ACUTE KIDNEY INJURY  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
NEPHROLITHIASIS  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
RENAL FAILURE  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA  1  2/34 (5.88%)  1/34 (2.94%)  0/35 (0.00%) 
HYPOXIA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
LUNG CONSOLIDATION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
PLEURAL EFFUSION  1  0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%) 
PNEUMONIA ASPIRATION  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
PNEUMONITIS  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
PNEUMOTHORAX  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
PULMONARY EMBOLISM  1  0/34 (0.00%)  2/34 (5.88%)  1/35 (2.86%) 
PULMONARY OEDEMA  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders       
ACTINIC KERATOSIS  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
EXFOLIATIVE RASH  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
SUBCUTANEOUS EMPHYSEMA  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
URTICARIA  1  1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Vascular disorders       
DEEP VEIN THROMBOSIS  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
HYPERTENSIVE CRISIS  1  0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
HYPOTENSION  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
VENOUS THROMBOSIS LIMB  1  0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide 5 mg Lenalidomide 10 mg Lenalidomide 15 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/34 (100.00%)   34/34 (100.00%)   35/35 (100.00%) 
Blood and lymphatic system disorders       
ANAEMIA  1  11/34 (32.35%)  18/34 (52.94%)  15/35 (42.86%) 
AUTOIMMUNE HAEMOLYTIC ANAEMIA  1  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
FEBRILE NEUTROPENIA  1  2/34 (5.88%)  2/34 (5.88%)  2/35 (5.71%) 
LEUKOPENIA  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
LYMPH NODE PAIN  1  1/34 (2.94%)  2/34 (5.88%)  0/35 (0.00%) 
NEUTROPENIA  1  25/34 (73.53%)  30/34 (88.24%)  26/35 (74.29%) 
THROMBOCYTOPENIA  1  17/34 (50.00%)  25/34 (73.53%)  21/35 (60.00%) 
Cardiac disorders       
ANGINA PECTORIS  1  0/34 (0.00%)  1/34 (2.94%)  2/35 (5.71%) 
TACHYCARDIA  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Ear and labyrinth disorders       
VERTIGO  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
Eye disorders       
DRY EYE  1  3/34 (8.82%)  0/34 (0.00%)  0/35 (0.00%) 
LACRIMATION INCREASED  1  1/34 (2.94%)  1/34 (2.94%)  2/35 (5.71%) 
Gastrointestinal disorders       
ABDOMINAL DISTENSION  1  1/34 (2.94%)  3/34 (8.82%)  1/35 (2.86%) 
ABDOMINAL PAIN  1  3/34 (8.82%)  10/34 (29.41%)  6/35 (17.14%) 
ABDOMINAL PAIN UPPER  1  1/34 (2.94%)  3/34 (8.82%)  3/35 (8.57%) 
CONSTIPATION  1  11/34 (32.35%)  13/34 (38.24%)  13/35 (37.14%) 
DIARRHOEA  1  14/34 (41.18%)  18/34 (52.94%)  16/35 (45.71%) 
DRY MOUTH  1  1/34 (2.94%)  2/34 (5.88%)  6/35 (17.14%) 
DYSPEPSIA  1  1/34 (2.94%)  3/34 (8.82%)  0/35 (0.00%) 
DYSPHAGIA  1  3/34 (8.82%)  0/34 (0.00%)  1/35 (2.86%) 
GASTRITIS  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
NAUSEA  1  10/34 (29.41%)  15/34 (44.12%)  11/35 (31.43%) 
ORAL PAIN  1  2/34 (5.88%)  1/34 (2.94%)  0/35 (0.00%) 
STOMATITIS  1  3/34 (8.82%)  1/34 (2.94%)  4/35 (11.43%) 
VOMITING  1  8/34 (23.53%)  5/34 (14.71%)  8/35 (22.86%) 
General disorders       
ASTHENIA  1  4/34 (11.76%)  4/34 (11.76%)  4/35 (11.43%) 
CHEST DISCOMFORT  1  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
CHILLS  1  0/34 (0.00%)  2/34 (5.88%)  6/35 (17.14%) 
FATIGUE  1  18/34 (52.94%)  17/34 (50.00%)  23/35 (65.71%) 
INFLUENZA LIKE ILLNESS  1  1/34 (2.94%)  3/34 (8.82%)  0/35 (0.00%) 
LOCAL SWELLING  1  1/34 (2.94%)  2/34 (5.88%)  0/35 (0.00%) 
MALAISE  1  2/34 (5.88%)  1/34 (2.94%)  1/35 (2.86%) 
NON-CARDIAC CHEST PAIN  1  0/34 (0.00%)  2/34 (5.88%)  1/35 (2.86%) 
OEDEMA PERIPHERAL  1  6/34 (17.65%)  8/34 (23.53%)  5/35 (14.29%) 
PYREXIA  1  12/34 (35.29%)  15/34 (44.12%)  16/35 (45.71%) 
Hepatobiliary disorders       
CHOLELITHIASIS  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
HYPERBILIRUBINAEMIA  1  4/34 (11.76%)  2/34 (5.88%)  3/35 (8.57%) 
Immune system disorders       
HYPOGAMMAGLOBULINAEMIA  1  5/34 (14.71%)  0/34 (0.00%)  0/35 (0.00%) 
Infections and infestations       
BRONCHITIS  1  5/34 (14.71%)  2/34 (5.88%)  3/35 (8.57%) 
CELLULITIS  1  0/34 (0.00%)  2/34 (5.88%)  2/35 (5.71%) 
CYTOMEGALOVIRUS INFECTION  1  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
HERPES SIMPLEX  1  0/34 (0.00%)  0/34 (0.00%)  4/35 (11.43%) 
LABYRINTHITIS  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
LOCALISED INFECTION  1  0/34 (0.00%)  1/34 (2.94%)  2/35 (5.71%) 
LOWER RESPIRATORY TRACT INFECTION  1  2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%) 
NASOPHARYNGITIS  1  3/34 (8.82%)  0/34 (0.00%)  1/35 (2.86%) 
ORAL CANDIDIASIS  1  0/34 (0.00%)  3/34 (8.82%)  3/35 (8.57%) 
ORAL HERPES  1  2/34 (5.88%)  3/34 (8.82%)  4/35 (11.43%) 
OTITIS MEDIA  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
PHARYNGITIS  1  1/34 (2.94%)  1/34 (2.94%)  3/35 (8.57%) 
PNEUMONIA  1  2/34 (5.88%)  4/34 (11.76%)  5/35 (14.29%) 
RESPIRATORY TRACT INFECTION  1  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
RHINITIS  1  1/34 (2.94%)  3/34 (8.82%)  2/35 (5.71%) 
SALMONELLOSIS  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
SINUSITIS  1  4/34 (11.76%)  1/34 (2.94%)  3/35 (8.57%) 
SKIN INFECTION  1  1/34 (2.94%)  0/34 (0.00%)  3/35 (8.57%) 
STAPHYLOCOCCAL INFECTION  1  0/34 (0.00%)  2/34 (5.88%)  1/35 (2.86%) 
TOOTH INFECTION  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
UPPER RESPIRATORY TRACT INFECTION  1  8/34 (23.53%)  5/34 (14.71%)  3/35 (8.57%) 
URINARY TRACT INFECTION  1  4/34 (11.76%)  5/34 (14.71%)  2/35 (5.71%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  2/34 (5.88%)  1/34 (2.94%)  7/35 (20.00%) 
Injury, poisoning and procedural complications       
CONTUSION  1  3/34 (8.82%)  2/34 (5.88%)  2/35 (5.71%) 
LACERATION  1  2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
PROCEDURAL PAIN  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  6/34 (17.65%)  7/34 (20.59%)  5/35 (14.29%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/34 (8.82%)  4/34 (11.76%)  5/35 (14.29%) 
BLOOD ALKALINE PHOSPHATASE INCREASED  1  2/34 (5.88%)  3/34 (8.82%)  1/35 (2.86%) 
BLOOD CREATININE INCREASED  1  2/34 (5.88%)  1/34 (2.94%)  2/35 (5.71%) 
BLOOD IMMUNOGLOBULIN G DECREASED  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
BLOOD PHOSPHORUS DECREASED  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  2/34 (5.88%)  2/34 (5.88%)  0/35 (0.00%) 
WEIGHT DECREASED  1  7/34 (20.59%)  13/34 (38.24%)  10/35 (28.57%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  5/34 (14.71%)  11/34 (32.35%)  9/35 (25.71%) 
DEHYDRATION  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
HYPERCALCAEMIA  1  2/34 (5.88%)  2/34 (5.88%)  2/35 (5.71%) 
HYPERGLYCAEMIA  1  2/34 (5.88%)  2/34 (5.88%)  2/35 (5.71%) 
HYPERKALAEMIA  1  2/34 (5.88%)  1/34 (2.94%)  1/35 (2.86%) 
HYPOCALCAEMIA  1  3/34 (8.82%)  2/34 (5.88%)  2/35 (5.71%) 
HYPOKALAEMIA  1  5/34 (14.71%)  5/34 (14.71%)  5/35 (14.29%) 
HYPOMAGNESAEMIA  1  1/34 (2.94%)  4/34 (11.76%)  1/35 (2.86%) 
HYPONATRAEMIA  1  1/34 (2.94%)  1/34 (2.94%)  2/35 (5.71%) 
HYPOPHOSPHATAEMIA  1  1/34 (2.94%)  3/34 (8.82%)  2/35 (5.71%) 
TUMOUR LYSIS SYNDROME  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  6/34 (17.65%)  4/34 (11.76%)  2/35 (5.71%) 
BACK PAIN  1  4/34 (11.76%)  2/34 (5.88%)  10/35 (28.57%) 
BONE PAIN  1  0/34 (0.00%)  2/34 (5.88%)  2/35 (5.71%) 
MUSCLE SPASMS  1  6/34 (17.65%)  7/34 (20.59%)  11/35 (31.43%) 
MUSCULAR WEAKNESS  1  1/34 (2.94%)  2/34 (5.88%)  1/35 (2.86%) 
MUSCULOSKELETAL CHEST PAIN  1  1/34 (2.94%)  1/34 (2.94%)  2/35 (5.71%) 
MUSCULOSKELETAL PAIN  1  2/34 (5.88%)  1/34 (2.94%)  4/35 (11.43%) 
NECK PAIN  1  2/34 (5.88%)  2/34 (5.88%)  3/35 (8.57%) 
PAIN IN EXTREMITY  1  8/34 (23.53%)  5/34 (14.71%)  5/35 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
TUMOUR FLARE  1  17/34 (50.00%)  21/34 (61.76%)  23/35 (65.71%) 
Nervous system disorders       
DIZZINESS  1  6/34 (17.65%)  1/34 (2.94%)  4/35 (11.43%) 
DYSGEUSIA  1  3/34 (8.82%)  0/34 (0.00%)  3/35 (8.57%) 
HEADACHE  1  5/34 (14.71%)  4/34 (11.76%)  4/35 (11.43%) 
HYPOAESTHESIA  1  2/34 (5.88%)  2/34 (5.88%)  2/35 (5.71%) 
LETHARGY  1  2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%) 
NEUROPATHY PERIPHERAL  1  3/34 (8.82%)  1/34 (2.94%)  2/35 (5.71%) 
PARAESTHESIA  1  2/34 (5.88%)  2/34 (5.88%)  3/35 (8.57%) 
PERIPHERAL SENSORY NEUROPATHY  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
SOMNOLENCE  1  1/34 (2.94%)  2/34 (5.88%)  0/35 (0.00%) 
TREMOR  1  2/34 (5.88%)  2/34 (5.88%)  0/35 (0.00%) 
Psychiatric disorders       
ANXIETY  1  0/34 (0.00%)  1/34 (2.94%)  4/35 (11.43%) 
DEPRESSION  1  1/34 (2.94%)  3/34 (8.82%)  2/35 (5.71%) 
INSOMNIA  1  3/34 (8.82%)  4/34 (11.76%)  8/35 (22.86%) 
Renal and urinary disorders       
DYSURIA  1  2/34 (5.88%)  4/34 (11.76%)  1/35 (2.86%) 
HAEMATURIA  1  1/34 (2.94%)  2/34 (5.88%)  1/35 (2.86%) 
POLLAKIURIA  1  2/34 (5.88%)  1/34 (2.94%)  2/35 (5.71%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  10/34 (29.41%)  15/34 (44.12%)  12/35 (34.29%) 
DYSPHONIA  1  2/34 (5.88%)  0/34 (0.00%)  3/35 (8.57%) 
DYSPNOEA  1  7/34 (20.59%)  6/34 (17.65%)  9/35 (25.71%) 
DYSPNOEA EXERTIONAL  1  1/34 (2.94%)  4/34 (11.76%)  3/35 (8.57%) 
EPISTAXIS  1  2/34 (5.88%)  0/34 (0.00%)  3/35 (8.57%) 
HYPOXIA  1  1/34 (2.94%)  1/34 (2.94%)  3/35 (8.57%) 
NASAL CONGESTION  1  4/34 (11.76%)  2/34 (5.88%)  3/35 (8.57%) 
NASAL DRYNESS  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
OROPHARYNGEAL PAIN  1  6/34 (17.65%)  1/34 (2.94%)  9/35 (25.71%) 
PLEURAL EFFUSION  1  0/34 (0.00%)  2/34 (5.88%)  1/35 (2.86%) 
PRODUCTIVE COUGH  1  2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%) 
RHINORRHOEA  1  5/34 (14.71%)  0/34 (0.00%)  0/35 (0.00%) 
SINUS CONGESTION  1  2/34 (5.88%)  1/34 (2.94%)  2/35 (5.71%) 
Skin and subcutaneous tissue disorders       
ERYTHEMA  1  1/34 (2.94%)  5/34 (14.71%)  1/35 (2.86%) 
EXFOLIATIVE RASH  1  0/34 (0.00%)  1/34 (2.94%)  2/35 (5.71%) 
HYPERHIDROSIS  1  1/34 (2.94%)  2/34 (5.88%)  7/35 (20.00%) 
NIGHT SWEATS  1  6/34 (17.65%)  10/34 (29.41%)  11/35 (31.43%) 
PRURITUS  1  3/34 (8.82%)  4/34 (11.76%)  3/35 (8.57%) 
RASH  1  9/34 (26.47%)  8/34 (23.53%)  16/35 (45.71%) 
RASH ERYTHEMATOUS  1  1/34 (2.94%)  2/34 (5.88%)  1/35 (2.86%) 
RASH GENERALISED  1  2/34 (5.88%)  2/34 (5.88%)  1/35 (2.86%) 
RASH MACULAR  1  3/34 (8.82%)  0/34 (0.00%)  1/35 (2.86%) 
RASH MACULO-PAPULAR  1  1/34 (2.94%)  0/34 (0.00%)  3/35 (8.57%) 
RASH PRURITIC  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
SKIN EXFOLIATION  1  0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
SWELLING FACE  1  1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
URTICARIA PAPULAR  1  0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Vascular disorders       
HYPOTENSION  1  4/34 (11.76%)  4/34 (11.76%)  5/35 (14.29%) 
ORTHOSTATIC HYPOTENSION  1  3/34 (8.82%)  0/34 (0.00%)  1/35 (2.86%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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 from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: ClinicalTrialDisclosure@Celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00963105     History of Changes
Other Study ID Numbers: CC-5013-CLL-009
2009-009836-54 ( EudraCT Number )
First Submitted: August 20, 2009
First Posted: August 21, 2009
Results First Submitted: August 31, 2018
Results First Posted: October 2, 2018
Last Update Posted: October 31, 2018