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Trial record 40 of 190 for:    Oral Cancer | ( Map: Mexico )

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer (Mainsail)

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ClinicalTrials.gov Identifier: NCT00988208
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : September 5, 2013
Last Update Posted : April 4, 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 Prostate Cancer
Interventions Drug: Lenalidomide
Drug: Docetaxel
Drug: Prednisone
Drug: Placebo
Enrollment 1059
Recruitment Details Following a safety and efficacy data review by the Data Monitoring Committee( DMC), the trial was stopped for futility. At that time, 1059 participants had been randomized and 1046 treated with either lenalidomide plus docetaxel and prednisone or placebo plus docetaxel and prednisone. A data cutoff date of 13 January 2012 was established.
Pre-assignment Details Participants who had started a treatment cycle at the time of termination request were allowed to complete the cycle and have their discontinuation visit at the next cycle (21 days later). The safety follow-up of 28 days was also added to ensure all adverse events were followed.
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle. Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Period Title: Overall Study
Started 526 533
Treated 521 525
Completed 95 [1] 95 [2]
Not Completed 431 438
Reason Not Completed
Adverse Event             71             122
Disease Progression             103             89
Withdrawal by Subject             50             57
Death             9             15
Lost to Follow-up             2             3
Protocol Violation             9             2
Sponsor Decision             102             78
Clinical Progression             17             16
Biochemical Progression             21             7
Clinical Deterioration             7             14
Subject Decision/Investigator Discretion             32             32
Other             8             3
[1]
DP Completed = kept on treatment with docetaxel/prednisone; Placebo was discontinued in DP arm
[2]
DPL Completed = kept on treatment with docetaxel/prednisone; Lenalidomide discontinued in DPL arm
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL) Total
Hide Arm/Group Description Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle. Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle. Total of all reporting groups
Overall Number of Baseline Participants 526 533 1059
Hide Baseline Analysis Population Description
Includes those from the Intent to Treat population (ITT). The ITT population is defined as all participants who were randomized, independent of whether they received study treatment or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 526 participants 533 participants 1059 participants
68.4  (7.79) 68.9  (7.98) 68.7  (7.89)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
<65 years
171
  32.5%
163
  30.6%
334
  31.5%
> = to 65 years and < = 75years
246
  46.8%
244
  45.8%
490
  46.3%
>75 years
109
  20.7%
126
  23.6%
235
  22.2%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
male 526 533 1059
female 0 0 0
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
US or Canada
136
  25.9%
140
  26.3%
276
  26.1%
EU or Australia
329
  62.5%
330
  61.9%
659
  62.2%
Rest of World (Includes 4 additional countries)
61
  11.6%
63
  11.8%
124
  11.7%
[1]
Measure Description: Rest of World includes Israel, Russia, Mexico and South Africa
Race, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
White
433
  82.3%
436
  81.8%
869
  82.1%
Other or no answer
55
  10.5%
67
  12.6%
122
  11.5%
Black or African American
25
   4.8%
21
   3.9%
46
   4.3%
Asian
8
   1.5%
6
   1.1%
14
   1.3%
American Indian or Alaska Native
5
   1.0%
3
   0.6%
8
   0.8%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 526 participants 533 participants 1059 participants
86.4  (16.18) 86  (15.70) 86.2  (15.93)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 526 participants 533 participants 1059 participants
174.0  (7.81) 174.4  (7.38) 174.2  (7.60)
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 526 participants 533 participants 1059 participants
28.6  (5.02) 28.3  (4.60) 28.4  (4.81)
[1]
Measure Description: BMI or body mass index is a statistical benchmark that compares an individual’s height and weight.
Body Mass Index, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
<25 kg/m^2
134
  25.5%
138
  25.9%
272
  25.7%
25-30 kg/m^2
221
  42.0%
243
  45.6%
464
  43.8%
>30 kg/m^2
171
  32.5%
152
  28.5%
323
  30.5%
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
0 (Fully Active)
257
  48.9%
252
  47.3%
509
  48.1%
1 (Restrictive but ambulatory)
247
  47.0%
256
  48.0%
503
  47.5%
2 (Ambulatory but unable to work)
21
   4.0%
24
   4.5%
45
   4.2%
3 (Limited self-care)
1
   0.2%
0
   0.0%
1
   0.1%
Not specified
0
   0.0%
1
   0.2%
1
   0.1%
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient and determine appropriate treatment and prognosis.
Type of Disease Progression   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
Rising PSA only
146
  27.8%
159
  29.8%
305
  28.8%
Radiographic progression
380
  72.2%
374
  70.2%
754
  71.2%
[1]
Measure Description: Categories of specific indicators of disease progression type
Prior Radiotherapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
Yes
308
  58.6%
312
  58.5%
620
  58.5%
No
218
  41.4%
221
  41.5%
439
  41.5%
[1]
Measure Description: Participants who had been treated with prior radiation therapy
Prior Cancer Surgery   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
Yes
335
  63.7%
358
  67.2%
693
  65.4%
No
191
  36.3%
175
  32.8%
366
  34.6%
[1]
Measure Description: Participants who had undergone a surgical procedure associated with their prostate cancer diagnosis prior to study participation
Other Prior Anti-Cancer Therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
Yes
79
  15.0%
71
  13.3%
150
  14.2%
No
447
  85.0%
462
  86.7%
909
  85.8%
[1]
Measure Description: Participants who were treated with other types of anti-cancer therapies prior to participation in study
Baseline PSA (Prostate Specific Antigen) Levels   [1] 
Mean (Standard Deviation)
Unit of measure:  (ng/ml)
Number Analyzed 526 participants 533 participants 1059 participants
290.359  (659.1583) 316.501  (776.1133) 303.542  (720.2895)
[1]
Measure Description: Prostate-specific antigen (PSA) is a substance produced by the prostate gland. Elevated PSA levels may indicate prostate cancer or a noncancerous condition such as prostatitis or an enlarged prostate.
Metastatic Sites of Disease Outside of Prostate   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 526 participants 533 participants 1059 participants
Bone only
157
  29.8%
169
  31.7%
326
  30.8%
Soft tissues only
94
  17.9%
104
  19.5%
198
  18.7%
Both bone and Soft tissues
273
  51.9%
259
  48.6%
532
  50.2%
None
2
   0.4%
1
   0.2%
3
   0.3%
[1]
Measure Description: Specific sites of the body that have advanced spread of the prostate cancer.
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.
Time Frame From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population defined as all randomized patients irrespective of whether they received treatment or not.
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description:
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed 526 533
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(75.71 to NA)
77
(64.29 to 81.71)
[1]
Median overall survival was not reached for the DP arm as only 92 (17.5 %) of participants had died at the time of the data cut off.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel/Prednisone/Placebo (DP), Docetaxel/Prednisone/Lenalidomide (DPL)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments p-value is based on unstratified log-rank test
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
1.17 to 2.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan
Time Frame From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the Intent to treat population (ITT), defined as all randomized patients irrespective of whether they received treatment or not.
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description:
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed 526 533
Median (95% Confidence Interval)
Unit of Measure: Weeks
46
(42.14 to 53.57)
45
(38.0 to 46.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel/Prednisone/Placebo (DP), Docetaxel/Prednisone/Lenalidomide (DPL)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0187
Comments [Not Specified]
Method Log Rank
Comments P-value is based on unstratified log-rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.05 to 1.66
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
Hide Description Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones
Time Frame From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the ITT population
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description:
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed 526 533
Measure Type: Number
Unit of Measure: percentage of participants
24.3 22.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel/Prednisone/Placebo (DP), Docetaxel/Prednisone/Lenalidomide (DPL)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3975
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.884
Confidence Interval (2-Sided) 95%
0.665 to 1.176
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs)
Hide Description A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
Time Frame From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description:
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed 521 525
Measure Type: Number
Unit of Measure: participants
Any TEAE 512 517
Any TEAE related to lenalidomide or placebo 379 412
Any TEAE related to docetaxel/prednisone 475 481
Any severity grade 3-4 TEAE 303 381
Any serious AE (SAE) 171 279
Any SAE related to lenalidomide or placebo 62 167
Any SAE related to docetaxel/prednisone 86 182
Any AE causing discontinuation of lenalidomide/PBO 82 150
Any AE causing withdrawal of docetaxel/prednisone 127 169
Any TEAE leading to death 16 24
5.Secondary Outcome
Title Percentage of Participants Who Received Post-Study Therapies
Hide Description Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.
Time Frame The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description:
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed 521 525
Measure Type: Number
Unit of Measure: Percentage of Participants
70.8 69.0
6.Secondary Outcome
Title Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
Hide Description Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.
Time Frame The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment lenalidomide/placebo, Docetaxel, or Prednisone).
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description:
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed 521 525
Measure Type: Number
Unit of Measure: percentage of participants
Invasive Secondary Primary Malignancies 1.3 1.7
Non-invasive Secondary Primary Malignancies 0.4 1.0
7.Secondary Outcome
Title Time to Onset of Secondary Primary Malignancies
Hide Description Time of Onset of Secondary Primary Malignancies was considered an event of interest
Time Frame The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).
Arm/Group Title Docetaxel/Prednisone/Placebo (DP) Docetaxel/Prednisone/Lenalidomide (DPL)
Hide Arm/Group Description:
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
Overall Number of Participants Analyzed 521 525
Median (Full Range)
Unit of Measure: months
29.7
(0.6 to 48.7)
19.7
(3.7 to 65.0)
Time Frame From first dose of study treatment to 28 days after the last dose; as of the final analysis cut-off of 20 April 2017; median overall duration of treatment was 22.1 months for DPL and 27.0 months for the DP group
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel/Prednisone/Lenalidomide (DPL) Docetaxel/ Prednisone/and Placebo (DP)
Hide Arm/Group Description Participants received docetaxel 75 mg/m^2 by intravenous (IV) administration over 60 minutes on Day 1, prednisone 5 mg orally twice a day (BID) and lenalidomide 25 mg capsules daily (QD) on Days 1-14 in each 21-day treatment cycle. Participants received Docetaxel 75 mg/m^2 by intravenous (IV) administration over 30-60 minutes on Day 1, Prednisone 5 mg orally twice a day (BID) and identically matching placebo capsules daily (QD) on Days 1-14 in each 21-day treatment cycle.
All-Cause Mortality
Docetaxel/Prednisone/Lenalidomide (DPL) Docetaxel/ Prednisone/and Placebo (DP)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel/Prednisone/Lenalidomide (DPL) Docetaxel/ Prednisone/and Placebo (DP)
Affected / at Risk (%) Affected / at Risk (%)
Total   283/525 (53.90%)   176/521 (33.78%) 
Blood and lymphatic system disorders     
ANAEMIA  1  18/525 (3.43%)  12/521 (2.30%) 
DISSEMINATED INTRAVASCULAR COAGULATION  1  0/525 (0.00%)  1/521 (0.19%) 
FEBRILE BONE MARROW APLASIA  1  2/525 (0.38%)  1/521 (0.19%) 
FEBRILE NEUTROPENIA  1  52/525 (9.90%)  23/521 (4.41%) 
LEUKOPENIA  1  5/525 (0.95%)  6/521 (1.15%) 
LYMPHOPENIA  1  1/525 (0.19%)  0/521 (0.00%) 
NEUTROPENIA  1  32/525 (6.10%)  11/521 (2.11%) 
PANCYTOPENIA  1  4/525 (0.76%)  0/521 (0.00%) 
THROMBOCYTOPENIA  1  1/525 (0.19%)  0/521 (0.00%) 
THROMBOTIC THROMBOCYTOPENIC PURPURA  1  1/525 (0.19%)  0/521 (0.00%) 
Cardiac disorders     
ACUTE CORONARY SYNDROME  1  2/525 (0.38%)  1/521 (0.19%) 
ACUTE MYOCARDIAL INFARCTION  1  1/525 (0.19%)  2/521 (0.38%) 
ANGINA PECTORIS  1  1/525 (0.19%)  1/521 (0.19%) 
ANGINA UNSTABLE  1  1/525 (0.19%)  0/521 (0.00%) 
ARRHYTHMIA  1  2/525 (0.38%)  0/521 (0.00%) 
ATRIAL FIBRILLATION  1  14/525 (2.67%)  8/521 (1.54%) 
ATRIAL FLUTTER  1  1/525 (0.19%)  0/521 (0.00%) 
ATRIAL TACHYCARDIA  1  1/525 (0.19%)  1/521 (0.19%) 
ATRIAL THROMBOSIS  1  1/525 (0.19%)  0/521 (0.00%) 
ATRIOVENTRICULAR BLOCK COMPLETE  1  1/525 (0.19%)  0/521 (0.00%) 
BRADYCARDIA  1  1/525 (0.19%)  0/521 (0.00%) 
CARDIAC ARREST  1  1/525 (0.19%)  0/521 (0.00%) 
CARDIAC FAILURE  1  0/525 (0.00%)  2/521 (0.38%) 
CARDIAC FAILURE CONGESTIVE  1  2/525 (0.38%)  1/521 (0.19%) 
CARDIO-RESPIRATORY ARREST  1  1/525 (0.19%)  0/521 (0.00%) 
CARDIOGENIC SHOCK  1  1/525 (0.19%)  0/521 (0.00%) 
CARDIOVASCULAR DISORDER  1  1/525 (0.19%)  0/521 (0.00%) 
CORONARY ARTERY DISEASE  1  1/525 (0.19%)  0/521 (0.00%) 
CORONARY ARTERY OCCLUSION  1  0/525 (0.00%)  1/521 (0.19%) 
DIASTOLIC DYSFUNCTION  1  0/525 (0.00%)  1/521 (0.19%) 
DILATATION VENTRICULAR  1  1/525 (0.19%)  0/521 (0.00%) 
MYOCARDIAL INFARCTION  1  3/525 (0.57%)  1/521 (0.19%) 
PALPITATIONS  1  1/525 (0.19%)  0/521 (0.00%) 
PERICARDIAL EFFUSION  1  1/525 (0.19%)  0/521 (0.00%) 
RIGHT VENTRICULAR FAILURE  1  1/525 (0.19%)  0/521 (0.00%) 
SUPRAVENTRICULAR TACHYCARDIA  1  0/525 (0.00%)  1/521 (0.19%) 
TACHYARRHYTHMIA  1  1/525 (0.19%)  0/521 (0.00%) 
TACHYCARDIA PAROXYSMAL  1  0/525 (0.00%)  1/521 (0.19%) 
VENTRICULAR EXTRASYSTOLES  1  0/525 (0.00%)  1/521 (0.19%) 
Ear and labyrinth disorders     
MENIERE'S DISEASE  1  1/525 (0.19%)  0/521 (0.00%) 
Endocrine disorders     
ADRENAL INSUFFICIENCY  1  1/525 (0.19%)  0/521 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/525 (0.38%)  2/521 (0.38%) 
ABDOMINAL PAIN UPPER  1  1/525 (0.19%)  1/521 (0.19%) 
ANAL FISTULA  1  0/525 (0.00%)  1/521 (0.19%) 
ANAL HAEMORRHAGE  1  1/525 (0.19%)  1/521 (0.19%) 
ANAL ULCER  1  0/525 (0.00%)  1/521 (0.19%) 
COLITIS ISCHAEMIC  1  1/525 (0.19%)  0/521 (0.00%) 
CONSTIPATION  1  4/525 (0.76%)  2/521 (0.38%) 
DIARRHOEA  1  22/525 (4.19%)  5/521 (0.96%) 
DIARRHOEA HAEMORRHAGIC  1  1/525 (0.19%)  0/521 (0.00%) 
DIVERTICULUM  1  0/525 (0.00%)  1/521 (0.19%) 
DUODENAL ULCER  1  1/525 (0.19%)  0/521 (0.00%) 
DUODENAL ULCER HAEMORRHAGE  1  0/525 (0.00%)  1/521 (0.19%) 
ENTEROCOLITIS  1  1/525 (0.19%)  0/521 (0.00%) 
ENTEROVESICAL FISTULA  1  1/525 (0.19%)  0/521 (0.00%) 
FAECALOMA  1  1/525 (0.19%)  0/521 (0.00%) 
FEMORAL HERNIA, OBSTRUCTIVE  1  1/525 (0.19%)  0/521 (0.00%) 
GASTRIC HAEMORRHAGE  1  1/525 (0.19%)  1/521 (0.19%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/525 (0.00%)  2/521 (0.38%) 
GASTROINTESTINAL PERFORATION  1  1/525 (0.19%)  0/521 (0.00%) 
GASTROINTESTINAL ULCER HAEMORRHAGE  1  1/525 (0.19%)  0/521 (0.00%) 
HAEMATEMESIS  1  1/525 (0.19%)  0/521 (0.00%) 
INTESTINAL INFARCTION  1  1/525 (0.19%)  0/521 (0.00%) 
INTESTINAL OBSTRUCTION  1  3/525 (0.57%)  2/521 (0.38%) 
INTESTINAL PERFORATION  1  1/525 (0.19%)  0/521 (0.00%) 
LARGE INTESTINE PERFORATION  1  0/525 (0.00%)  1/521 (0.19%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  0/525 (0.00%)  1/521 (0.19%) 
MELAENA  1  0/525 (0.00%)  1/521 (0.19%) 
NAUSEA  1  4/525 (0.76%)  2/521 (0.38%) 
OESOPHAGEAL ULCER  1  0/525 (0.00%)  1/521 (0.19%) 
PANCREATITIS  1  0/525 (0.00%)  2/521 (0.38%) 
RECTAL HAEMORRHAGE  1  2/525 (0.38%)  4/521 (0.77%) 
RETROPERITONEAL HAEMATOMA  1  0/525 (0.00%)  1/521 (0.19%) 
SMALL INTESTINAL OBSTRUCTION  1  2/525 (0.38%)  1/521 (0.19%) 
SUBILEUS  1  1/525 (0.19%)  0/521 (0.00%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/525 (0.00%)  2/521 (0.38%) 
VOMITING  1  8/525 (1.52%)  3/521 (0.58%) 
General disorders     
ASTHENIA  1  5/525 (0.95%)  2/521 (0.38%) 
CHILLS  1  1/525 (0.19%)  0/521 (0.00%) 
DEATH  1  0/525 (0.00%)  1/521 (0.19%) 
DEVICE OCCLUSION  1  0/525 (0.00%)  2/521 (0.38%) 
FATIGUE  1  4/525 (0.76%)  2/521 (0.38%) 
GAIT DISTURBANCE  1  0/525 (0.00%)  1/521 (0.19%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  11/525 (2.10%)  5/521 (0.96%) 
GENERALISED OEDEMA  1  1/525 (0.19%)  0/521 (0.00%) 
MALAISE  1  1/525 (0.19%)  0/521 (0.00%) 
MULTI-ORGAN FAILURE  1  1/525 (0.19%)  1/521 (0.19%) 
NON-CARDIAC CHEST PAIN  1  4/525 (0.76%)  2/521 (0.38%) 
OEDEMA PERIPHERAL  1  0/525 (0.00%)  2/521 (0.38%) 
PAIN  1  1/525 (0.19%)  0/521 (0.00%) 
PERFORMANCE STATUS DECREASED  1  1/525 (0.19%)  0/521 (0.00%) 
PYREXIA  1  19/525 (3.62%)  6/521 (1.15%) 
THROMBOSIS IN DEVICE  1  1/525 (0.19%)  0/521 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/525 (0.19%)  0/521 (0.00%) 
CHOLECYSTITIS ACUTE  1  1/525 (0.19%)  0/521 (0.00%) 
CHOLELITHIASIS  1  1/525 (0.19%)  0/521 (0.00%) 
GALLBLADDER PERFORATION  1  1/525 (0.19%)  0/521 (0.00%) 
HYPERBILIRUBINAEMIA  1  1/525 (0.19%)  0/521 (0.00%) 
Immune system disorders     
DRUG HYPERSENSITIVITY  1  3/525 (0.57%)  1/521 (0.19%) 
Infections and infestations     
ABDOMINAL ABSCESS  1  0/525 (0.00%)  1/521 (0.19%) 
ABSCESS BACTERIAL  1  1/525 (0.19%)  1/521 (0.19%) 
ABSCESS JAW  1  1/525 (0.19%)  0/521 (0.00%) 
ANAL ABSCESS  1  1/525 (0.19%)  0/521 (0.00%) 
APPENDICITIS  1  1/525 (0.19%)  0/521 (0.00%) 
APPENDICITIS PERFORATED  1  0/525 (0.00%)  1/521 (0.19%) 
BACTERAEMIA  1  2/525 (0.38%)  1/521 (0.19%) 
BRONCHITIS  1  2/525 (0.38%)  0/521 (0.00%) 
BRONCHOPNEUMONIA  1  1/525 (0.19%)  0/521 (0.00%) 
CAMPYLOBACTER GASTROENTERITIS  1  1/525 (0.19%)  1/521 (0.19%) 
CANDIDIASIS  1  1/525 (0.19%)  0/521 (0.00%) 
CELLULITIS  1  3/525 (0.57%)  3/521 (0.58%) 
CLOSTRIDIUM DIFFICILE COLITIS  1  2/525 (0.38%)  0/521 (0.00%) 
DEVICE RELATED INFECTION  1  2/525 (0.38%)  0/521 (0.00%) 
DIARRHOEA INFECTIOUS  1  0/525 (0.00%)  1/521 (0.19%) 
DIVERTICULITIS  1  1/525 (0.19%)  0/521 (0.00%) 
ENTEROCOLITIS INFECTIOUS  1  1/525 (0.19%)  0/521 (0.00%) 
ERYSIPELAS  1  0/525 (0.00%)  1/521 (0.19%) 
ESCHERICHIA SEPSIS  1  1/525 (0.19%)  1/521 (0.19%) 
ESCHERICHIA URINARY TRACT INFECTION  1  1/525 (0.19%)  0/521 (0.00%) 
GASTROENTERITIS  1  0/525 (0.00%)  1/521 (0.19%) 
GROIN ABSCESS  1  1/525 (0.19%)  0/521 (0.00%) 
H1N1 INFLUENZA  1  1/525 (0.19%)  0/521 (0.00%) 
HERPES ZOSTER  1  1/525 (0.19%)  0/521 (0.00%) 
HORDEOLUM  1  0/525 (0.00%)  1/521 (0.19%) 
INCISION SITE CELLULITIS  1  0/525 (0.00%)  1/521 (0.19%) 
INFECTIOUS PERITONITIS  1  1/525 (0.19%)  0/521 (0.00%) 
INFECTIVE TENOSYNOVITIS  1  1/525 (0.19%)  0/521 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  2/525 (0.38%)  1/521 (0.19%) 
LUNG INFECTION  1  4/525 (0.76%)  0/521 (0.00%) 
LYMPHANGITIS  1  0/525 (0.00%)  1/521 (0.19%) 
NECROTISING FASCIITIS  1  1/525 (0.19%)  0/521 (0.00%) 
NEUTROPENIC INFECTION  1  2/525 (0.38%)  1/521 (0.19%) 
NEUTROPENIC SEPSIS  1  15/525 (2.86%)  6/521 (1.15%) 
ORAL CANDIDIASIS  1  1/525 (0.19%)  0/521 (0.00%) 
ORAL INFECTION  1  1/525 (0.19%)  0/521 (0.00%) 
OSTEOMYELITIS  1  1/525 (0.19%)  0/521 (0.00%) 
PNEUMOCYSTIS JIROVECI PNEUMONIA  1  2/525 (0.38%)  0/521 (0.00%) 
PNEUMONIA  1  24/525 (4.57%)  8/521 (1.54%) 
PNEUMONIA BACTERIAL  1  0/525 (0.00%)  1/521 (0.19%) 
PNEUMONIA INFLUENZAL  1  1/525 (0.19%)  0/521 (0.00%) 
PNEUMONIA LEGIONELLA  1  1/525 (0.19%)  0/521 (0.00%) 
PSEUDOMONAL BACTERAEMIA  1  1/525 (0.19%)  1/521 (0.19%) 
PSEUDOMONAL SEPSIS  1  1/525 (0.19%)  0/521 (0.00%) 
PYELONEPHRITIS  1  1/525 (0.19%)  1/521 (0.19%) 
RECTAL ABSCESS  1  1/525 (0.19%)  0/521 (0.00%) 
RESPIRATORY SYNCYTIAL VIRUS INFECTION  1  1/525 (0.19%)  0/521 (0.00%) 
RESPIRATORY TRACT INFECTION  1  1/525 (0.19%)  1/521 (0.19%) 
RESPIRATORY TRACT INFECTION BACTERIAL  1  0/525 (0.00%)  1/521 (0.19%) 
SEPSIS  1  3/525 (0.57%)  9/521 (1.73%) 
SEPTIC SHOCK  1  3/525 (0.57%)  1/521 (0.19%) 
SINUSITIS  1  1/525 (0.19%)  0/521 (0.00%) 
SKIN INFECTION  1  2/525 (0.38%)  0/521 (0.00%) 
STREPTOCOCCAL INFECTION  1  0/525 (0.00%)  1/521 (0.19%) 
TONSILLITIS  1  1/525 (0.19%)  0/521 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  2/525 (0.38%)  0/521 (0.00%) 
URETHRITIS  1  0/525 (0.00%)  1/521 (0.19%) 
URINARY TRACT INFECTION  1  10/525 (1.90%)  7/521 (1.34%) 
URINARY TRACT INFECTION BACTERIAL  1  1/525 (0.19%)  1/521 (0.19%) 
URINARY TRACT INFECTION ENTEROCOCCAL  1  0/525 (0.00%)  1/521 (0.19%) 
URINARY TRACT INFECTION FUNGAL  1  0/525 (0.00%)  1/521 (0.19%) 
UROSEPSIS  1  2/525 (0.38%)  1/521 (0.19%) 
VESTIBULAR NEURONITIS  1  0/525 (0.00%)  1/521 (0.19%) 
VIRAL INFECTION  1  1/525 (0.19%)  0/521 (0.00%) 
WOUND INFECTION  1  0/525 (0.00%)  1/521 (0.19%) 
Injury, poisoning and procedural complications     
ACCIDENTAL OVERDOSE  1  1/525 (0.19%)  0/521 (0.00%) 
FEMORAL NECK FRACTURE  1  1/525 (0.19%)  1/521 (0.19%) 
FIBULA FRACTURE  1  0/525 (0.00%)  1/521 (0.19%) 
FOOT FRACTURE  1  0/525 (0.00%)  1/521 (0.19%) 
HIP FRACTURE  1  0/525 (0.00%)  2/521 (0.38%) 
HUMERUS FRACTURE  1  2/525 (0.38%)  0/521 (0.00%) 
INFUSION RELATED REACTION  1  1/525 (0.19%)  1/521 (0.19%) 
JOINT DISLOCATION  1  1/525 (0.19%)  0/521 (0.00%) 
LOWER LIMB FRACTURE  1  0/525 (0.00%)  1/521 (0.19%) 
MUSCLE RUPTURE  1  1/525 (0.19%)  0/521 (0.00%) 
PELVIC FRACTURE  1  1/525 (0.19%)  0/521 (0.00%) 
RIB FRACTURE  1  2/525 (0.38%)  0/521 (0.00%) 
SUBDURAL HAEMATOMA  1  1/525 (0.19%)  0/521 (0.00%) 
THORACIC VERTEBRAL FRACTURE  1  1/525 (0.19%)  0/521 (0.00%) 
TIBIA FRACTURE  1  0/525 (0.00%)  1/521 (0.19%) 
TRAUMATIC LIVER INJURY  1  1/525 (0.19%)  0/521 (0.00%) 
Investigations     
BLOOD CREATININE INCREASED  1  1/525 (0.19%)  0/521 (0.00%) 
BLOOD UREA INCREASED  1  1/525 (0.19%)  0/521 (0.00%) 
INTERNATIONAL NORMALISED RATIO INCREASED  1  0/525 (0.00%)  1/521 (0.19%) 
NEUTROPHIL COUNT DECREASED  1  2/525 (0.38%)  0/521 (0.00%) 
PLATELET COUNT DECREASED  1  0/525 (0.00%)  1/521 (0.19%) 
TROPONIN INCREASED  1  1/525 (0.19%)  0/521 (0.00%) 
URINE OUTPUT DECREASED  1  0/525 (0.00%)  1/521 (0.19%) 
WHITE BLOOD CELL COUNT DECREASED  1  1/525 (0.19%)  0/521 (0.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  2/525 (0.38%)  0/521 (0.00%) 
DEHYDRATION  1  13/525 (2.48%)  4/521 (0.77%) 
DIABETES MELLITUS INADEQUATE CONTROL  1  0/525 (0.00%)  1/521 (0.19%) 
DIABETIC KETOACIDOSIS  1  0/525 (0.00%)  1/521 (0.19%) 
GOUT  1  1/525 (0.19%)  0/521 (0.00%) 
HYPERGLYCAEMIA  1  2/525 (0.38%)  2/521 (0.38%) 
HYPOCALCAEMIA  1  3/525 (0.57%)  1/521 (0.19%) 
HYPOGLYCAEMIA  1  0/525 (0.00%)  3/521 (0.58%) 
HYPOKALAEMIA  1  1/525 (0.19%)  1/521 (0.19%) 
HYPONATRAEMIA  1  2/525 (0.38%)  0/521 (0.00%) 
HYPOPHOSPHATAEMIA  1  0/525 (0.00%)  1/521 (0.19%) 
HYPOVOLAEMIA  1  1/525 (0.19%)  0/521 (0.00%) 
METABOLIC ACIDOSIS  1  1/525 (0.19%)  0/521 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  2/525 (0.38%)  1/521 (0.19%) 
ARTHRITIS  1  1/525 (0.19%)  0/521 (0.00%) 
BACK PAIN  1  5/525 (0.95%)  2/521 (0.38%) 
BONE PAIN  1  1/525 (0.19%)  4/521 (0.77%) 
BURSITIS  1  1/525 (0.19%)  0/521 (0.00%) 
FISTULA  1  1/525 (0.19%)  0/521 (0.00%) 
FLANK PAIN  1  1/525 (0.19%)  0/521 (0.00%) 
MUSCULAR WEAKNESS  1  1/525 (0.19%)  0/521 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  1/525 (0.19%)  2/521 (0.38%) 
OSTEONECROSIS OF JAW  1  1/525 (0.19%)  1/521 (0.19%) 
PAIN IN EXTREMITY  1  3/525 (0.57%)  1/521 (0.19%) 
PATHOLOGICAL FRACTURE  1  2/525 (0.38%)  0/521 (0.00%) 
SPINAL OSTEOARTHRITIS  1  1/525 (0.19%)  0/521 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
COLON CANCER METASTATIC  1  1/525 (0.19%)  0/521 (0.00%) 
LYMPHOCYTIC LYMPHOMA  1  0/525 (0.00%)  1/521 (0.19%) 
METASTATIC PAIN  1  0/525 (0.00%)  1/521 (0.19%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  0/525 (0.00%)  1/521 (0.19%) 
SUPERFICIAL SPREADING MELANOMA STAGE I  1  1/525 (0.19%)  0/521 (0.00%) 
THYROID CANCER  1  1/525 (0.19%)  0/521 (0.00%) 
Nervous system disorders     
CAROTID ARTERY OCCLUSION  1  2/525 (0.38%)  0/521 (0.00%) 
CAROTID ARTERY STENOSIS  1  1/525 (0.19%)  0/521 (0.00%) 
CEREBRAL ISCHAEMIA  1  1/525 (0.19%)  0/521 (0.00%) 
CEREBROVASCULAR ACCIDENT  1  1/525 (0.19%)  3/521 (0.58%) 
DIZZINESS  1  2/525 (0.38%)  0/521 (0.00%) 
DYSKINESIA  1  0/525 (0.00%)  1/521 (0.19%) 
HYPOAESTHESIA  1  1/525 (0.19%)  0/521 (0.00%) 
ISCHAEMIC STROKE  1  2/525 (0.38%)  0/521 (0.00%) 
LACUNAR INFARCTION  1  1/525 (0.19%)  0/521 (0.00%) 
PARKINSON'S DISEASE  1  1/525 (0.19%)  0/521 (0.00%) 
PRESYNCOPE  1  1/525 (0.19%)  0/521 (0.00%) 
SCIATICA  1  1/525 (0.19%)  0/521 (0.00%) 
SPINAL CORD COMPRESSION  1  1/525 (0.19%)  3/521 (0.58%) 
SYNCOPE  1  8/525 (1.52%)  4/521 (0.77%) 
TRANSIENT ISCHAEMIC ATTACK  1  5/525 (0.95%)  0/521 (0.00%) 
TREMOR  1  1/525 (0.19%)  0/521 (0.00%) 
Psychiatric disorders     
ANXIETY  1  0/525 (0.00%)  2/521 (0.38%) 
COMPLETED SUICIDE  1  1/525 (0.19%)  0/521 (0.00%) 
DELIRIUM  1  1/525 (0.19%)  0/521 (0.00%) 
MENTAL STATUS CHANGES  1  0/525 (0.00%)  2/521 (0.38%) 
Renal and urinary disorders     
CALCULUS URETHRAL  1  0/525 (0.00%)  1/521 (0.19%) 
CYSTITIS HAEMORRHAGIC  1  0/525 (0.00%)  1/521 (0.19%) 
DYSURIA  1  1/525 (0.19%)  1/521 (0.19%) 
HAEMATURIA  1  5/525 (0.95%)  9/521 (1.73%) 
HYDRONEPHROSIS  1  0/525 (0.00%)  4/521 (0.77%) 
NEPHROLITHIASIS  1  0/525 (0.00%)  2/521 (0.38%) 
RENAL FAILURE  1  0/525 (0.00%)  1/521 (0.19%) 
RENAL FAILURE ACUTE  1  10/525 (1.90%)  4/521 (0.77%) 
RENAL INJURY  1  2/525 (0.38%)  0/521 (0.00%) 
URETERIC OBSTRUCTION  1  0/525 (0.00%)  1/521 (0.19%) 
URETHRAL OBSTRUCTION  1  1/525 (0.19%)  0/521 (0.00%) 
URINARY RETENTION  1  3/525 (0.57%)  3/521 (0.58%) 
Reproductive system and breast disorders     
PELVIC PAIN  1  0/525 (0.00%)  1/521 (0.19%) 
PENILE HAEMORRHAGE  1  0/525 (0.00%)  1/521 (0.19%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY DISTRESS SYNDROME  1  1/525 (0.19%)  1/521 (0.19%) 
ACUTE RESPIRATORY FAILURE  1  1/525 (0.19%)  1/521 (0.19%) 
ALVEOLITIS ALLERGIC  1  1/525 (0.19%)  0/521 (0.00%) 
ASTHMA  1  0/525 (0.00%)  1/521 (0.19%) 
BRONCHOSPASM  1  1/525 (0.19%)  0/521 (0.00%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/525 (0.00%)  2/521 (0.38%) 
COUGH  1  2/525 (0.38%)  0/521 (0.00%) 
DYSPNOEA  1  13/525 (2.48%)  2/521 (0.38%) 
DYSPNOEA EXERTIONAL  1  1/525 (0.19%)  1/521 (0.19%) 
EPISTAXIS  1  1/525 (0.19%)  1/521 (0.19%) 
HYPOXIA  1  1/525 (0.19%)  0/521 (0.00%) 
INTERSTITIAL LUNG DISEASE  1  3/525 (0.57%)  0/521 (0.00%) 
LUNG DISORDER  1  1/525 (0.19%)  0/521 (0.00%) 
PLEURAL EFFUSION  1  1/525 (0.19%)  0/521 (0.00%) 
PNEUMONIA ASPIRATION  1  1/525 (0.19%)  0/521 (0.00%) 
PNEUMONITIS  1  3/525 (0.57%)  0/521 (0.00%) 
PNEUMOTHORAX  1  1/525 (0.19%)  1/521 (0.19%) 
PULMONARY EMBOLISM  1  34/525 (6.48%)  8/521 (1.54%) 
PULMONARY FIBROSIS  1  0/525 (0.00%)  1/521 (0.19%) 
PULMONARY HYPERTENSION  1  1/525 (0.19%)  0/521 (0.00%) 
RESPIRATORY FAILURE  1  1/525 (0.19%)  0/521 (0.00%) 
SLEEP APNOEA SYNDROME  1  0/525 (0.00%)  1/521 (0.19%) 
Skin and subcutaneous tissue disorders     
DERMATITIS EXFOLIATIVE  1  0/525 (0.00%)  1/521 (0.19%) 
RASH  1  1/525 (0.19%)  0/521 (0.00%) 
SKIN EXFOLIATION  1  0/525 (0.00%)  1/521 (0.19%) 
Vascular disorders     
ARTERIAL THROMBOSIS LIMB  1  1/525 (0.19%)  0/521 (0.00%) 
DEEP VEIN THROMBOSIS  1  13/525 (2.48%)  3/521 (0.58%) 
EMBOLISM  1  1/525 (0.19%)  1/521 (0.19%) 
HAEMATOMA  1  0/525 (0.00%)  1/521 (0.19%) 
HYPERTENSION  1  0/525 (0.00%)  1/521 (0.19%) 
HYPOTENSION  1  8/525 (1.52%)  7/521 (1.34%) 
JUGULAR VEIN THROMBOSIS  1  0/525 (0.00%)  1/521 (0.19%) 
PERIPHERAL ISCHAEMIA  1  0/525 (0.00%)  2/521 (0.38%) 
THROMBOPHLEBITIS  1  2/525 (0.38%)  0/521 (0.00%) 
VENA CAVA THROMBOSIS  1  1/525 (0.19%)  0/521 (0.00%) 
VENOUS THROMBOSIS  1  1/525 (0.19%)  0/521 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel/Prednisone/Lenalidomide (DPL) Docetaxel/ Prednisone/and Placebo (DP)
Affected / at Risk (%) Affected / at Risk (%)
Total   513/525 (97.71%)   511/521 (98.08%) 
Blood and lymphatic system disorders     
ANAEMIA  1  154/525 (29.33%)  94/521 (18.04%) 
LEUKOPENIA  1  40/525 (7.62%)  34/521 (6.53%) 
NEUTROPENIA  1  125/525 (23.81%)  94/521 (18.04%) 
THROMBOCYTOPENIA  1  39/525 (7.43%)  18/521 (3.45%) 
Eye disorders     
LACRIMATION INCREASED  1  53/525 (10.10%)  63/521 (12.09%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  55/525 (10.48%)  36/521 (6.91%) 
CONSTIPATION  1  144/525 (27.43%)  124/521 (23.80%) 
DIARRHOEA  1  236/525 (44.95%)  204/521 (39.16%) 
DYSPEPSIA  1  41/525 (7.81%)  30/521 (5.76%) 
NAUSEA  1  170/525 (32.38%)  153/521 (29.37%) 
STOMATITIS  1  50/525 (9.52%)  37/521 (7.10%) 
VOMITING  1  93/525 (17.71%)  63/521 (12.09%) 
General disorders     
ASTHENIA  1  124/525 (23.62%)  117/521 (22.46%) 
FATIGUE  1  238/525 (45.33%)  232/521 (44.53%) 
MUCOSAL INFLAMMATION  1  37/525 (7.05%)  43/521 (8.25%) 
OEDEMA PERIPHERAL  1  146/525 (27.81%)  134/521 (25.72%) 
PYREXIA  1  92/525 (17.52%)  74/521 (14.20%) 
Infections and infestations     
NASOPHARYNGITIS  1  46/525 (8.76%)  37/521 (7.10%) 
URINARY TRACT INFECTION  1  36/525 (6.86%)  32/521 (6.14%) 
Investigations     
WEIGHT DECREASED  1  96/525 (18.29%)  54/521 (10.36%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  125/525 (23.81%)  105/521 (20.15%) 
DEHYDRATION  1  38/525 (7.24%)  23/521 (4.41%) 
HYPERGLYCAEMIA  1  35/525 (6.67%)  36/521 (6.91%) 
HYPOKALAEMIA  1  63/525 (12.00%)  22/521 (4.22%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  86/525 (16.38%)  73/521 (14.01%) 
BACK PAIN  1  88/525 (16.76%)  91/521 (17.47%) 
BONE PAIN  1  59/525 (11.24%)  66/521 (12.67%) 
MUSCLE SPASMS  1  85/525 (16.19%)  46/521 (8.83%) 
MUSCULAR WEAKNESS  1  25/525 (4.76%)  30/521 (5.76%) 
MUSCULOSKELETAL CHEST PAIN  1  31/525 (5.90%)  27/521 (5.18%) 
MUSCULOSKELETAL PAIN  1  39/525 (7.43%)  29/521 (5.57%) 
MYALGIA  1  44/525 (8.38%)  55/521 (10.56%) 
PAIN IN EXTREMITY  1  57/525 (10.86%)  66/521 (12.67%) 
Nervous system disorders     
DIZZINESS  1  61/525 (11.62%)  48/521 (9.21%) 
DYSGEUSIA  1  113/525 (21.52%)  124/521 (23.80%) 
HEADACHE  1  42/525 (8.00%)  51/521 (9.79%) 
PARAESTHESIA  1  34/525 (6.48%)  65/521 (12.48%) 
PERIPHERAL SENSORY NEUROPATHY  1  99/525 (18.86%)  130/521 (24.95%) 
Psychiatric disorders     
INSOMNIA  1  60/525 (11.43%)  64/521 (12.28%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  108/525 (20.57%)  76/521 (14.59%) 
DYSPNOEA  1  104/525 (19.81%)  88/521 (16.89%) 
EPISTAXIS  1  37/525 (7.05%)  52/521 (9.98%) 
OROPHARYNGEAL PAIN  1  30/525 (5.71%)  20/521 (3.84%) 
Skin and subcutaneous tissue disorders     
ALOPECIA  1  223/525 (42.48%)  226/521 (43.38%) 
DRY SKIN  1  39/525 (7.43%)  50/521 (9.60%) 
NAIL DISCOLOURATION  1  22/525 (4.19%)  32/521 (6.14%) 
NAIL DISORDER  1  41/525 (7.81%)  59/521 (11.32%) 
ONYCHOMADESIS  1  14/525 (2.67%)  28/521 (5.37%) 
PRURITUS  1  46/525 (8.76%)  10/521 (1.92%) 
RASH  1  61/525 (11.62%)  59/521 (11.32%) 
Vascular disorders     
HYPERTENSION  1  16/525 (3.05%)  33/521 (6.33%) 
HYPOTENSION  1  35/525 (6.67%)  24/521 (4.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
The independent DMC concluded that it was unlikely the trial would achieve its primary endpoint of improved overall survival. The sponsor agreed and the experimental lenalidomide/placebo treatment arm of the study was discontinued.
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.
Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. It has priority over subset (single center) publication, for duration of 24 months after study completion. Individual investigators have publication rights after multicenter publication is complete (or 24 months after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 60 days.
Results Point of Contact
Name/Title: Senior Manager , Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00988208     History of Changes
Other Study ID Numbers: CC-5013-PC-002
EudraCT Number 2008-007969-23
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: June 27, 2013
Results First Posted: September 5, 2013
Last Update Posted: April 4, 2018