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MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00833833
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : April 25, 2013
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Pomalidomide
Drug: Dexamethasone
Drug: Aspirin
Enrollment 259
Recruitment Details  
Pre-assignment Details Phase 2: Participants were stratified by age (≤ 75 vs. > 75), prior number of treatments (2 vs. > 2), and prior thalidomide exposure (yes vs. no).
Arm/Group Title Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide
Hide Arm/Group Description Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle. 4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
Period Title: Phase 1 (as of 01 April 2011)
Started 6 8 14 10 0 0
Completed 2 [1] 3 [1] 5 [1] 4 [1] 0 0
Not Completed 4 5 9 6 0 0
Reason Not Completed
Still active in study             0             0             2             2             0             0
Withdrawal by Subject             1             1             2             2             0             0
Adverse Event             1             0             2             1             0             0
Death             0             1             2             0             0             0
Disease progression - unconfirmed             1             0             1             0             0             0
Other             1             3             0             1             0             0
[1]
Confirmed progressive disease
Period Title: Phase 2 (as of 01 April 2011)
Started 0 0 0 0 113 108
Safety Population 0 0 0 0 112 107
Completed 0 0 0 0 58 [1] 47 [1]
Not Completed 0 0 0 0 55 61
Reason Not Completed
Still active in study             0             0             0             0             23             22
Adverse Event             0             0             0             0             8             13
Death             0             0             0             0             8             9
Disease progression - unconfirmed             0             0             0             0             7             6
Withdrawal by Subject             0             0             0             0             5             7
Other             0             0             0             0             4             3
Lost to Follow-up             0             0             0             0             0             1
[1]
Confirmed progressive disease
Arm/Group Title Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide Total
Hide Arm/Group Description Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle. 4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment. Total of all reporting groups
Overall Number of Baseline Participants 6 8 14 10 113 108 259
Hide Baseline Analysis Population Description
Intent to treat population from both phases
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
64.7  (6.83) 70.4  (6.63) 67.5  (8.98) 61.3  (14.06) 64.4  (9.24) 62.9  (10.35) 64.1  (9.86)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
<=75 years 6 6 11 9 99 95 226
>75 years 0 2 3 1 14 13 33
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
Female
5
  83.3%
5
  62.5%
4
  28.6%
6
  60.0%
51
  45.1%
51
  47.2%
122
  47.1%
Male
1
  16.7%
3
  37.5%
10
  71.4%
4
  40.0%
62
  54.9%
57
  52.8%
137
  52.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
Asian 0 0 0 2 2 3 7
Black or African American 1 0 0 0 17 16 34
White 5 8 14 8 92 86 213
Other 0 0 0 0 2 3 5
Baseline Electrocardiogram Findings  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
Normal 3 3 3 4 53 44 110
Abnormal, not clinically significant 3 5 11 6 56 59 140
Abnormal, clinically significant 0 0 0 0 0 1 1
Missing 0 0 0 0 4 4 8
Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
0 1 0 3 2 32 24 62
1 1 8 10 5 68 71 163
2 4 0 1 3 13 11 32
3 0 0 0 0 0 2 2
[1]
Measure Description:

The ECOG scale is as follows:

Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.

Baseline Multiple Myeloma Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
Stage I 1 1 3 2 8 8 23
Stage II 0 1 4 1 29 29 64
Stage III 5 6 7 7 76 71 172
[1]
Measure Description: Multiple myeloma has three stages, which are known as stage I, stage II and stage III. Staging in myeloma is done on the basis of the value of serum albumin and beta-2 microglobulin level. Stage I has the best prognosis and stage III the worst prognosis.
Prior Anti-Myeloma Therapies  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
Yes 6 8 14 10 113 108 259
No 0 0 0 0 0 0 0
Prior Thalidomide Exposure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
Yes 4 6 11 9 76 72 178
No 2 2 3 1 37 36 81
Prior Stem Cell Transplant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants 10 participants 113 participants 108 participants 259 participants
Yes 4 4 11 6 84 82 191
No 2 4 3 4 29 26 68
1.Primary Outcome
Title Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1
Hide Description

The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.

DLTs were defined as:

  • Grade 4 neutropenia or thrombocytopenia
  • Febrile neutropenia
  • Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment
  • Serum transaminase > 20 * upper limit of normal (ULN)
  • Serum transaminase > 5 * ULN for >= 7 days
  • Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event
Time Frame Up to Day 28 (Cycle 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide
Hide Arm/Group Description:
Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Overall Number of Participants Analyzed 6 8 14 10
Measure Type: Number
Unit of Measure: participants
1 1 2 4
2.Primary Outcome
Title Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off
Hide Description

Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).

For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.

Data collection is ongoing and future data results will be included as available.

Time Frame up to 67 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide
Hide Arm/Group Description:
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
Overall Number of Participants Analyzed 113 108
Median (95% Confidence Interval)
Unit of Measure: weeks
16.6
(14.1 to 21.1)
10.7
(8.3 to 16.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Pomalidomide + Dexamethasone, Phase 2: Pomalidomide
Comments With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.54 to 0.99
Estimation Comments [Not Specified]
3.Primary Outcome
Title Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off
Hide Description

Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).

Data collection is ongoing and future data results will be included as available.

Time Frame up to 67 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide
Hide Arm/Group Description:
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
Overall Number of Participants Analyzed 113 108
Measure Type: Number
Unit of Measure: percentage of participants
76.1 75.0
4.Secondary Outcome
Title Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off
Hide Description

Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.

Data collection is ongoing and future data results will be included as available.

Time Frame Up to week 104
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide
Hide Arm/Group Description:
Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Overall Number of Participants Analyzed 6 8 14 10
Measure Type: Number
Unit of Measure: percentage of participants
1 or more (1+) AE 100.0 100.0 100.0 100.0
1+ AE related to pomalidomide 66.7 75.0 85.7 100.0
1+ severity grade 3-4 AE 83.3 37.5 78.6 80.0
1+ severity grade 3-4 AE related to pomalidomide 33.3 25.0 42.9 70.0
1+ serious AE (SAE) 50.0 12.5 42.9 30.0
1+ SAE related to pomalidomide 0.0 12.5 7.1 10.0
1+ AE leading to discontinuation of pomalidomide 16.7 0.0 21.4 0.0
1+AE-dose reduction/interruption of pomalidomide 16.7 75.0 42.9 80.0
1+related AE-reduction/interruption of pomalidomid 0.0 37.5 28.6 70.0
5.Secondary Outcome
Title Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off
Hide Description

TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.

Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.

Data collection is ongoing and future data results will be included as available.

Time Frame Up to week 126
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide
Hide Arm/Group Description:
Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
Overall Number of Participants Analyzed 1 4 10 7
Measure Type: Number
Unit of Measure: percentage of participants
1 or more (1+) AE 100.0 100.0 90.0 100.0
1+ AE related to pomalidomide 100.0 75.0 80.0 100.0
1+ AE related to dexamethasone 100.0 75.0 70.0 85.7
1+ severity grade 3-4 AE 0.0 75.0 70.0 57.1
1+ severity grade 3-4 AE related to pomalidomide 0.0 75.0 20.0 42.9
1+ severity grade 3-4 AE related to dexamethasone 0.0 75.0 20.0 0.0
1+ serious AE (SAE) 0.0 75.0 40.0 28.6
1+ SAE related to pomalidomide 0.0 25.0 20.0 0.0
1+ SAE related to dexamethasone 0.0 50.0 10.0 0.0
1+ AE leading to discontinuation of pomalidomide 0.0 25.0 20.0 0.0
1+ AE -- discontinuation of dexamethasone 0.0 25.0 20.0 0.0
1+AE -dose reduction/interruption of pomalidomide 0.0 50.0 40.0 71.4
1+ AE-dose reduction/interruption of dexamethasone 0.0 75.0 60.0 71.4
1+related AE-reduction/interruption of pomalidomid 0.0 25.0 20.0 57.1
1+related AE-reduction/interruption of dexamethaso 0.0 75.0 20.0 42.9
6.Secondary Outcome
Title Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off
Hide Description

Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.

Data collection is ongoing and future data results will be included as available.

Time Frame Up to week 70
Hide Outcome Measure Data
Hide Analysis Population Description

Safety population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide (Pom Only) Phase 2: Pomalidomide (Pom + Dex Only) Phase 2: Pomalidomide (Overall)
Hide Arm/Group Description:
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.

Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.

Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.

Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.

Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone.

Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.

Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.

Overall Number of Participants Analyzed 112 107 61 107
Measure Type: Number
Unit of Measure: percentage of participants
1 or more (1+) AE 100.0 99.1 93.4 100.0
1+ AE related to pomalidomide 89.3 87.9 68.9 88.8
1+ severity grade 3-4 AE 88.4 84.1 70.5 89.7
1+ severity grade 3-4 AE related to pomalidomide 62.5 58.9 44.3 67.3
1+ serious AE (SAE) 61.6 46.7 47.5 67.3
1+ SAE related to pomalidomide 17.9 9.3 19.7 20.6
1+ AE leading to discontinuation of pomalidomide 8.0 10.3 3.3 12.1
1+related AE --discontinuation of pomalidomide 1.8 2.8 1.6 3.7
1+AE - reduction of pomalidomide 20.5 25.2 9.8 29.9
1+ AE - interruption of pomalidomide 63.4 47.7 36.1 58.9
1+ related AE - interruption of pomalidomide 27.7 24.3 21.3 32.7
1+related AE - reduction of pomalidomide 17.9 20.6 8.2 24.3
7.Secondary Outcome
Title Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off
Hide Description

IRAC used EBMT criteria to assess myeloma response:

  • Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)
  • Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others
  • Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others
  • Stable Disease (SD)- not MR or progressive disease (PD)
  • Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other
  • Not Evaluable (NE).

Data collection is ongoing and future data results will be included as available.

Time Frame up to 70 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide
Hide Arm/Group Description:
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
Overall Number of Participants Analyzed 113 108
Measure Type: Number
Unit of Measure: percentage of participants
Complete response (CR) 0.9 0.0
Partial response (PR) 29.2 9.3
Minimal response (MR) 15.0 15.7
Stable disease (SD) 35.4 46.3
Progressive disease (PD) 6.2 15.7
Not evaluable 13.3 13.0
8.Secondary Outcome
Title Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off
Hide Description

Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.

Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome.

Time Frame up to 70 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Responders (participants with a complete response or partial response) from the ITT population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide
Hide Arm/Group Description:
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
Overall Number of Participants Analyzed 34 10
Median (95% Confidence Interval)
Unit of Measure: weeks
32.1
(22.1 to 39.9)
NA [1] 
(NA to NA)
[1]
Not estimable since 9 or 10 responders were censored. The median was not reached at the time of the data cut-off.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Pomalidomide + Dexamethasone, Phase 2: Pomalidomide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 6.25
Confidence Interval (2-Sided) 95%
0.84 to 46.66
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Phase 2: Time to Response as of the 01 April 2011 Cut-off
Hide Description

Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.

Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.

Data collection is ongoing and future data results will be included as available.

Time Frame up to 70 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

Responders (participants achieving CR or PR) from ITT population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide
Hide Arm/Group Description:
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
Overall Number of Participants Analyzed 34 10
Median (Full Range)
Unit of Measure: weeks
8.1
(3.7 to 45.1)
8.9
(4.1 to 49.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Pomalidomide + Dexamethasone, Phase 2: Pomalidomide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off
Hide Description

Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.

Data collection is ongoing and future data results will be included as available.

Time Frame up to 70 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

ITT population.

Data collection is ongoing and future data results will be included as available.

Arm/Group Title Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide
Hide Arm/Group Description:
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
Overall Number of Participants Analyzed 113 108
Median (95% Confidence Interval)
Unit of Measure: weeks
62.6 [1] 
(53.6 to NA)
59.3 [2] 
(41.6 to NA)
[1]
Not estimable due to 69 out of 113 patients were still alive at data cutoff date
[2]
Not estimable due to 61 out of 108 patients were still alive at data cutoff date
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 2: Pomalidomide + Dexamethasone, Phase 2: Pomalidomide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.57 to 1.29
Estimation Comments [Not Specified]
Time Frame Data cut-off 01 April 2011 Phase 1: up to 126 weeks Phase 2: up to 70 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide (Pom Only) Phase 2: Pomalidomide (Pom + Dex Only) Phase 2: Pomalidomide (Overall)
Hide Arm/Group Description Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone. Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.

Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.

Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.

Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.

Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone.

Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.

Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.

All-Cause Mortality
Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide (Pom Only) Phase 2: Pomalidomide (Pom + Dex Only) Phase 2: Pomalidomide (Overall)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide (Pom Only) Phase 2: Pomalidomide (Pom + Dex Only) Phase 2: Pomalidomide (Overall)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   4/8 (50.00%)   8/14 (57.14%)   4/10 (40.00%)   69/112 (61.61%)   50/107 (46.73%)   29/61 (47.54%)   72/107 (67.29%) 
Blood and lymphatic system disorders                 
Febrile neutropenia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  2/107 (1.87%)  3/61 (4.92%)  5/107 (4.67%) 
Anemia  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Neutropenia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  2/112 (1.79%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Thrombocytopenia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  2/112 (1.79%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Hyperviscosity syndrome  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Leukopenia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Cardiac disorders                 
Atrial fibrillation  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  3/112 (2.68%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Cardiac failure congestive  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  3/112 (2.68%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Angina pectoris  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Cardio-respiratory arrest  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Cardio-respiratory distress  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Myocardial ischaemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Atrioventricular block second degree  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Gastrointestinal disorders                 
Constipation  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  3/112 (2.68%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Nausea  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Diarrhoea  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Intestinal obstruction  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Vomiting  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Abdominal pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Abdominal pain upper  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Ascites  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Caecitis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Peptic ulcer  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Rectal haemorrhage  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Gastrointestinal haemorrhage  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
General disorders                 
Pyrexia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  5/112 (4.46%)  3/107 (2.80%)  0/61 (0.00%)  3/107 (2.80%) 
Fatigue  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
General physical health deterioration  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Non-cardiac chest pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Asthenia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Catheter site haemorrhage  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Chest pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Malaise  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Hepatobiliary disorders                 
Cholecystitis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Hyperbilirubinaemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Infections and infestations                 
Pneumonia  1  1/6 (16.67%)  0/8 (0.00%)  2/14 (14.29%)  0/10 (0.00%)  21/112 (18.75%)  10/107 (9.35%)  6/61 (9.84%)  15/107 (14.02%) 
Sepsis  1  1/6 (16.67%)  2/8 (25.00%)  0/14 (0.00%)  1/10 (10.00%)  3/112 (2.68%)  4/107 (3.74%)  2/61 (3.28%)  6/107 (5.61%) 
Urinary tract infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  6/112 (5.36%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Bronchopneumonia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Cellulitis  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Lobar pneumonia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  2/61 (3.28%)  2/107 (1.87%) 
Pneumonia respiratory syncytial viral  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Respiratory syncytial virus infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Urosepsis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Viral infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Arthritis baterial  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Bacteraemia  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Bronchitis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Bronchopulmonary aspergillosis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Clostridium difficile colitis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Device related infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Escherichia bacteraemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Gastroenteritis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
H1N1 influenza  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Herpes zoster disseminated  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Herpes zoster ophthalmic  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pneumonia fungal  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pneumonia parainfluenzae viral  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pneumonia streptococcal  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Pneumonia viral  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Postoperative wound infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pseudomonas infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Pyelonephritis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Septic shock  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Skin infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Staphylococcal bacteraemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Staphylococcal infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Staphylococcal sepsis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Abscess limb  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Arthritis infective  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Influenza  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Lung infection pseudomonal  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Meningitis bacterial  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pharyngeal abscess  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Injury, poisoning and procedural complications                 
Compression fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Fall  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Femur fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Hip fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Humerus fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Spinal compression fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Subdural haematoma  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Accidental overdose  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Femoral neck fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pelvic fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Toxicity to various agents  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Upper limb fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Investigations                 
Blood creatinine increased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Haemoglobin decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Blood culture positive  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Electrocardiogram QT prolonged  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Neutrophil count decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Platelet count decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Metabolism and nutrition disorders                 
Dehydration  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  3/112 (2.68%)  4/107 (3.74%)  1/61 (1.64%)  5/107 (4.67%) 
Hypercalcaemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  3/107 (2.80%)  2/61 (3.28%)  5/107 (4.67%) 
Failure to thrive  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Hyperkalaemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Decreased appetite  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Fluid overload  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Hyponatraemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Tumour lysis syndrome  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Musculoskeletal and connective tissue disorders                 
Back pain  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  2/112 (1.79%)  2/107 (1.87%)  3/61 (4.92%)  4/107 (3.74%) 
Bone pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Muscular weakness  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Musculoskeletal chest pain  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Musculoskeletal pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Neck pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Pain in extremity  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Multiple myeloma  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  8/112 (7.14%)  9/107 (8.41%)  1/61 (1.64%)  10/107 (9.35%) 
Cancer pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Colon cancer  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Leukaemia plasmacytic  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Metastases to meninges  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Nervous system disorders                 
Cerebral haemorrhage  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Brain mass  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Cauda equina syndrome  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Dizziness  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Dysarthria  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Spinal cord compression  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Subarachnoid haemorrhage  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Syncope  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Unresponsive to stimuli  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Headache  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Psychiatric disorders                 
Confusional state  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  2/61 (3.28%)  2/107 (1.87%) 
Mental status changes  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  2/61 (3.28%)  2/107 (1.87%) 
Completed suicide  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Psychotic disorder  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Renal and urinary disorders                 
Renal failure acute  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  6/112 (5.36%)  5/107 (4.67%)  2/61 (3.28%)  7/107 (6.54%) 
Renal failure  1  1/6 (16.67%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Nephrolithiasis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Renal failure chronic  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Renal impairment  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Respiratory, thoracic and mediastinal disorders                 
Dyspnoea  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  7/112 (6.25%)  2/107 (1.87%)  3/61 (4.92%)  5/107 (4.67%) 
Bronchospasm  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pulmonary embolism  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Respiratory failure  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Acute respiratory failure  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Chronic obstructive pulmonary disease  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Epistaxis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Hypoxia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Interstitial lung disease  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Pleural effusion  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Pleuritic pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Pneumonia aspiration  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Respiratory distress  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Lung infiltration  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Skin and subcutaneous tissue disorders                 
Rash  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Vascular disorders                 
Deep vein thrombosis  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Hypotension  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Thrombosis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase 1: 2 mg Pomalidomide Phase 1: 3 mg Pomalidomide Phase 1: 4 mg Pomalidomide Phase 1: 5 mg Pomalidomide Phase 2: Pomalidomide + Dexamethasone Phase 2: Pomalidomide (Pom Only) Phase 2: Pomalidomide (Pom + Dex Only) Phase 2: Pomalidomide (Overall)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   8/8 (100.00%)   14/14 (100.00%)   10/10 (100.00%)   112/112 (100.00%)   105/107 (98.13%)   57/61 (93.44%)   106/107 (99.07%) 
Blood and lymphatic system disorders                 
Neutropenia  1  1/6 (16.67%)  5/8 (62.50%)  8/14 (57.14%)  9/10 (90.00%)  52/112 (46.43%)  53/107 (49.53%)  17/61 (27.87%)  55/107 (51.40%) 
Anaemia  1  5/6 (83.33%)  4/8 (50.00%)  5/14 (35.71%)  3/10 (30.00%)  43/112 (38.39%)  36/107 (33.64%)  11/61 (18.03%)  41/107 (38.32%) 
Thrombocytopenia  1  2/6 (33.33%)  3/8 (37.50%)  2/14 (14.29%)  3/10 (30.00%)  24/112 (21.43%)  25/107 (23.36%)  7/61 (11.48%)  27/107 (25.23%) 
Leukopenia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  19/112 (16.96%)  11/107 (10.28%)  2/61 (3.28%)  12/107 (11.21%) 
Lymphopenia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  17/112 (15.18%)  4/107 (3.74%)  0/61 (0.00%)  4/107 (3.74%) 
Lymphadenopathy  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  3/112 (2.68%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Cardiac disorders                 
Atrial fibrillation  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  9/112 (8.04%)  3/107 (2.80%)  1/61 (1.64%)  4/107 (3.74%) 
Bradycardia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Ear and labyrinth disorders                 
Ear pain  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Tinnitus  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Deafness  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Endocrine disorders                 
Cushingoid  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  3/112 (2.68%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Eye disorders                 
Vision blurred  1  0/6 (0.00%)  1/8 (12.50%)  2/14 (14.29%)  3/10 (30.00%)  9/112 (8.04%)  4/107 (3.74%)  0/61 (0.00%)  4/107 (3.74%) 
Dry eye  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  3/112 (2.68%)  3/107 (2.80%)  1/61 (1.64%)  4/107 (3.74%) 
Cataract  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Conjunctivitis  1  0/6 (0.00%)  0/8 (0.00%)  2/14 (14.29%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Diplopia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Eyelid disorder  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Ocular hyperaemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Photophobia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Periorbital oedema  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Gastrointestinal disorders                 
Constipation  1  2/6 (33.33%)  1/8 (12.50%)  2/14 (14.29%)  4/10 (40.00%)  38/112 (33.93%)  29/107 (27.10%)  11/61 (18.03%)  38/107 (35.51%) 
Diarrhoea  1  1/6 (16.67%)  1/8 (12.50%)  2/14 (14.29%)  4/10 (40.00%)  37/112 (33.04%)  22/107 (20.56%)  17/61 (27.87%)  35/107 (32.71%) 
Nausea  1  2/6 (33.33%)  1/8 (12.50%)  3/14 (21.43%)  5/10 (50.00%)  24/112 (21.43%)  29/107 (27.10%)  10/61 (16.39%)  37/107 (34.58%) 
Vomiting  1  1/6 (16.67%)  2/8 (25.00%)  4/14 (28.57%)  2/10 (20.00%)  15/112 (13.39%)  10/107 (9.35%)  4/61 (6.56%)  14/107 (13.08%) 
Dry mouth  1  1/6 (16.67%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  8/112 (7.14%)  9/107 (8.41%)  0/61 (0.00%)  9/107 (8.41%) 
Abdominal distension  1  0/6 (0.00%)  1/8 (12.50%)  2/14 (14.29%)  1/10 (10.00%)  5/112 (4.46%)  5/107 (4.67%)  3/61 (4.92%)  8/107 (7.48%) 
Abdominal pain  1  0/6 (0.00%)  1/8 (12.50%)  2/14 (14.29%)  1/10 (10.00%)  8/112 (7.14%)  3/107 (2.80%)  1/61 (1.64%)  4/107 (3.74%) 
Dyspepsia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  2/10 (20.00%)  4/112 (3.57%)  2/107 (1.87%)  1/61 (1.64%)  3/107 (2.80%) 
Abdominal pain upper  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  7/112 (6.25%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Flatulence  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  3/112 (2.68%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Faecal incontinence  1  0/6 (0.00%)  0/8 (0.00%)  2/14 (14.29%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Gastrooesophageal reflux disease  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Sensitivity of teeth  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Gingival pain  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Hypoaesthesia oral  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Haemorrhoids  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Haematochezia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Oesophagitis  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
General disorders                 
Fatigue  1  4/6 (66.67%)  5/8 (62.50%)  9/14 (64.29%)  7/10 (70.00%)  62/112 (55.36%)  46/107 (42.99%)  11/61 (18.03%)  53/107 (49.53%) 
Pyrexia  1  2/6 (33.33%)  2/8 (25.00%)  3/14 (21.43%)  3/10 (30.00%)  31/112 (27.68%)  15/107 (14.02%)  6/61 (9.84%)  19/107 (17.76%) 
Oedema peripheral  1  2/6 (33.33%)  1/8 (12.50%)  1/14 (7.14%)  2/10 (20.00%)  18/112 (16.07%)  18/107 (16.82%)  8/61 (13.11%)  25/107 (23.36%) 
Asthenia  1  3/6 (50.00%)  2/8 (25.00%)  1/14 (7.14%)  0/10 (0.00%)  22/112 (19.64%)  11/107 (10.28%)  5/61 (8.20%)  15/107 (14.02%) 
Chills  1  1/6 (16.67%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  12/112 (10.71%)  9/107 (8.41%)  2/61 (3.28%)  10/107 (9.35%) 
Malaise  1  0/6 (0.00%)  2/8 (25.00%)  2/14 (14.29%)  3/10 (30.00%)  4/112 (3.57%)  5/107 (4.67%)  1/61 (1.64%)  6/107 (5.61%) 
Gait disturbance  1  1/6 (16.67%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  4/112 (3.57%)  6/107 (5.61%)  3/61 (4.92%)  8/107 (7.48%) 
Pain  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  5/112 (4.46%)  5/107 (4.67%)  1/61 (1.64%)  6/107 (5.61%) 
Irritability  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  4/112 (3.57%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Mucosal inflammation  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  3/112 (2.68%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Non-cardiac chest pain  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  3/112 (2.68%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Feeling jittery  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  3/112 (2.68%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Influenza like illness  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  1/107 (0.93%)  2/61 (3.28%)  3/107 (2.80%) 
Feeling abnormal  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Catheter site haemorrhage  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Feeling hot  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Immune system disorders                 
Allergic oedema  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Infections and infestations                 
Upper respiratory tract infection  1  0/6 (0.00%)  2/8 (25.00%)  5/14 (35.71%)  2/10 (20.00%)  23/112 (20.54%)  17/107 (15.89%)  10/61 (16.39%)  27/107 (25.23%) 
Urinary tract infection  1  0/6 (0.00%)  1/8 (12.50%)  3/14 (21.43%)  1/10 (10.00%)  15/112 (13.39%)  7/107 (6.54%)  2/61 (3.28%)  8/107 (7.48%) 
Pneumonia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  8/112 (7.14%)  6/107 (5.61%)  5/61 (8.20%)  1/107 (0.93%) 
Nasopharyngitis  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  1/10 (10.00%)  4/112 (3.57%)  2/107 (1.87%)  4/61 (6.56%)  6/107 (5.61%) 
Sinusitis  1  1/6 (16.67%)  0/8 (0.00%)  3/14 (21.43%)  2/10 (20.00%)  5/112 (4.46%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Rhinitis  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  1/10 (10.00%)  2/112 (1.79%)  4/107 (3.74%)  1/61 (1.64%)  5/107 (4.67%) 
Candidiasis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  6/112 (5.36%)  0/107 (0.00%)  2/61 (3.28%)  2/107 (1.87%) 
Oral candidiasis  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  6/112 (5.36%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Bronchitis  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  3/112 (2.68%)  1/107 (0.93%)  2/61 (3.28%)  3/107 (2.80%) 
Fungal skin infection  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  1/10 (10.00%)  2/112 (1.79%)  1/107 (0.93%)  1/61 (1.64%)  1/107 (0.93%) 
Tooth infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  3/107 (2.80%)  0/61 (0.00%)  3/107 (2.80%) 
Herpes zoster  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  2/10 (20.00%)  0/112 (0.00%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Respiratory tract infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Lower respiratory tract infection  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Sepsis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Vulvovaginal mycotic infection  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Gastroenteritis  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Localised infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Post procedural infection  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Urethritis  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Arthritis infective  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Herpes simplex  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Lung infection  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Urinary tract infection bacterial  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Urinary tract infection fungal  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Injury, poisoning and procedural complications                 
Contusion  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  5/112 (4.46%)  1/107 (0.93%)  2/61 (3.28%)  3/107 (2.80%) 
Spinal compression fracture  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  3/112 (2.68%)  4/107 (3.74%)  3/61 (4.92%)  5/107 (4.67%) 
Procedural pain  1  1/6 (16.67%)  1/8 (12.50%)  0/14 (0.00%)  1/10 (10.00%)  2/112 (1.79%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Excoriation  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  3/112 (2.68%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Tendon injury  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Wound dehiscence  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Investigations                 
Blood creatinine increased  1  0/6 (0.00%)  0/8 (0.00%)  3/14 (21.43%)  0/10 (0.00%)  12/112 (10.71%)  11/107 (10.28%)  6/61 (9.84%)  14/107 (13.08%) 
Weight decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  9/112 (8.04%)  9/107 (8.41%)  5/61 (8.20%)  15/107 (14.02%) 
Weight increased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  12/112 (10.71%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  7/112 (6.25%)  5/107 (4.67%)  0/61 (0.00%)  5/107 (4.67%) 
Neutrophil count decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  8/112 (7.14%)  5/107 (4.67%)  1/61 (1.64%)  5/107 (4.67%) 
White blood cell count decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  8/112 (7.14%)  4/107 (3.74%)  0/61 (0.00%)  4/107 (3.74%) 
Haemoglobin decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  8/112 (7.14%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Blood glucose increased  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  2/107 (1.87%)  1/61 (1.64%)  3/107 (2.80%) 
Platelet count decreased  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  5/112 (4.46%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
International normalised ratio increased  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  3/112 (2.68%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Cardiac murmur  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Blood phosphorus decreased  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Heart rate irregular  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Liver function test abnormal  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Blood potassium decreased  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Blood urine present  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Metabolism and nutrition disorders                 
Decreased appetite  1  1/6 (16.67%)  2/8 (25.00%)  3/14 (21.43%)  3/10 (30.00%)  19/112 (16.96%)  15/107 (14.02%)  8/61 (13.11%)  23/107 (21.50%) 
Hypercalcaemia  1  1/6 (16.67%)  1/8 (12.50%)  0/14 (0.00%)  1/10 (10.00%)  11/112 (9.82%)  17/107 (15.89%)  3/61 (4.92%)  18/107 (16.82%) 
Hyperglycaemia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  17/112 (15.18%)  10/107 (9.35%)  4/61 (6.56%)  13/107 (12.15%) 
Hyponatraemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  14/112 (12.50%)  7/107 (6.54%)  3/61 (4.92%)  10/107 (9.35%) 
Hypokalaemia  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  12/112 (10.71%)  6/107 (5.61%)  5/61 (8.20%)  11/107 (10.28%) 
Hypocalcaemia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  13/112 (11.61%)  5/107 (4.67%)  2/61 (3.28%)  6/107 (5.61%) 
Dehydration  1  2/6 (33.33%)  1/8 (12.50%)  2/14 (14.29%)  0/10 (0.00%)  5/112 (4.46%)  4/107 (3.74%)  1/61 (1.64%)  4/107 (3.74%) 
Hypoalbuminaemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  7/112 (6.25%)  4/107 (3.74%)  3/61 (4.92%)  7/107 (6.54%) 
Hyperkalaemia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  9/112 (8.04%)  4/107 (3.74%)  0/61 (0.00%)  4/107 (3.74%) 
Hyperuricaemia  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  4/112 (3.57%)  7/107 (6.54%)  0/61 (0.00%)  7/107 (6.54%) 
Hypomagnesaemia  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  5/112 (4.46%)  4/107 (3.74%)  2/61 (3.28%)  5/107 (4.67%) 
Hypophosphataemia  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  8/112 (7.14%)  2/107 (1.87%)  1/61 (1.64%)  3/107 (2.80%) 
Hypermagnesaemia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  2/112 (1.79%)  1/107 (0.93%)  1/61 (1.64%)  1/107 (0.93%) 
Cachexia  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Back pain  1  3/6 (50.00%)  0/8 (0.00%)  3/14 (21.43%)  1/10 (10.00%)  32/112 (28.57%)  26/107 (24.30%)  10/61 (16.39%)  33/107 (30.84%) 
Muscle spasms  1  2/6 (33.33%)  1/8 (12.50%)  6/14 (42.86%)  2/10 (20.00%)  21/112 (18.75%)  17/107 (15.89%)  7/61 (11.48%)  20/107 (18.69%) 
Musculoskeletal chest pain  1  1/6 (16.67%)  1/8 (12.50%)  1/14 (7.14%)  2/10 (20.00%)  21/112 (18.75%)  16/107 (14.95%)  8/61 (13.11%)  22/107 (20.56%) 
Arthralgia  1  1/6 (16.67%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  17/112 (15.18%)  14/107 (13.08%)  3/61 (4.92%)  17/107 (15.89%) 
Musculoskeletal pain  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  3/10 (30.00%)  17/112 (15.18%)  8/107 (7.48%)  4/61 (6.56%)  12/107 (11.21%) 
Muscular weakness  1  0/6 (0.00%)  0/8 (0.00%)  2/14 (14.29%)  0/10 (0.00%)  12/112 (10.71%)  8/107 (7.48%)  5/61 (8.20%)  13/107 (12.15%) 
Pain in extremity  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  2/10 (20.00%)  15/112 (13.39%)  4/107 (3.74%)  1/61 (1.64%)  5/107 (4.67%) 
Bone pain  1  1/6 (16.67%)  0/8 (0.00%)  1/14 (7.14%)  2/10 (20.00%)  5/112 (4.46%)  7/107 (6.54%)  6/61 (9.84%)  12/107 (11.21%) 
Myalgia  1  0/6 (0.00%)  0/8 (0.00%)  2/14 (14.29%)  1/10 (10.00%)  5/112 (4.46%)  4/107 (3.74%)  2/61 (3.28%)  6/107 (5.61%) 
Neck pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  3/107 (2.80%)  3/61 (4.92%)  6/107 (5.61%) 
Pain in jaw  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  2/112 (1.79%)  1/107 (0.93%)  2/61 (3.28%)  3/107 (2.80%) 
Groin pain  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  2/112 (1.79%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Joint swelling  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Flank pain  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Bone lesion  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Bursitis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Musculoskeletal stiffness  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Osteonecrosis  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Bone infarction  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Musculoskeletal discomfort  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Polymyalgia rheumatica  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Squamous cell carcinoma of skin  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Basal cell carcinoma  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Squamous cell carcinoma  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Nervous system disorders                 
Dizziness  1  0/6 (0.00%)  2/8 (25.00%)  4/14 (28.57%)  2/10 (20.00%)  19/112 (16.96%)  16/107 (14.95%)  4/61 (6.56%)  20/107 (18.69%) 
Headache  1  0/6 (0.00%)  0/8 (0.00%)  3/14 (21.43%)  2/10 (20.00%)  9/112 (8.04%)  12/107 (11.21%)  2/61 (3.28%)  14/107 (13.08%) 
Tremor  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  2/10 (20.00%)  14/112 (12.50%)  7/107 (6.54%)  3/61 (4.92%)  10/107 (9.35%) 
Neuropathy peripheral  1  1/6 (16.67%)  0/8 (0.00%)  1/14 (7.14%)  3/10 (30.00%)  8/112 (7.14%)  11/107 (10.28%)  0/61 (0.00%)  11/107 (10.28%) 
Paraesthesia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  2/10 (20.00%)  4/112 (3.57%)  4/107 (3.74%)  2/61 (3.28%)  5/107 (4.67%) 
Somnolence  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  6/112 (5.36%)  3/107 (2.80%)  1/61 (1.64%)  4/107 (3.74%) 
Dysgeusia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  8/112 (7.14%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Hypoaesthesia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  2/112 (1.79%)  4/107 (3.74%)  2/61 (3.28%)  6/107 (5.61%) 
Numb chin syndrome  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  1/10 (10.00%)  3/112 (2.68%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Ataxia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  2/112 (1.79%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Balance disorder  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  2/107 (1.87%)  0/61 (0.00%)  2/107 (1.87%) 
Sciatica  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Aphasia  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  1/61 (1.64%)  1/107 (0.93%) 
Post herpetic neuralgia  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Sensory disturbance  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Subarachnoid haemorrhage  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Psychiatric disorders                 
Insomnia  1  0/6 (0.00%)  0/8 (0.00%)  4/14 (28.57%)  1/10 (10.00%)  16/112 (14.29%)  0/107 (0.00%)  7/61 (11.48%)  7/107 (6.54%) 
Confusional state  1  1/6 (16.67%)  2/8 (25.00%)  1/14 (7.14%)  0/10 (0.00%)  14/112 (12.50%)  6/107 (5.61%)  3/61 (4.92%)  9/107 (8.41%) 
Anxiety  1  0/6 (0.00%)  1/8 (12.50%)  2/14 (14.29%)  0/10 (0.00%)  8/112 (7.14%)  9/107 (8.41%)  3/61 (4.92%)  12/107 (11.21%) 
Depression  1  0/6 (0.00%)  0/8 (0.00%)  3/14 (21.43%)  2/10 (20.00%)  3/112 (2.68%)  3/107 (2.80%)  3/61 (4.92%)  6/107 (5.61%) 
Mood altered  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  6/112 (5.36%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Agitation  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  3/112 (2.68%)  1/107 (0.93%)  2/61 (3.28%)  3/107 (2.80%) 
Mental status changes  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  4/112 (3.57%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Affect lability  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Mania  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Renal and urinary disorders                 
Renal failure acute  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  4/107 (3.74%)  2/61 (3.28%)  6/107 (5.61%) 
Urinary incontinence  1  1/6 (16.67%)  0/8 (0.00%)  2/14 (14.29%)  0/10 (0.00%)  3/112 (2.68%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Dysuria  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  0/107 (0.00%)  3/61 (4.92%)  3/107 (2.80%) 
Haematuria  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  2/112 (1.79%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Pollakiuria  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Cystitis noninfective  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Dyspnoea  1  3/6 (50.00%)  6/8 (75.00%)  2/14 (14.29%)  3/10 (30.00%)  33/112 (29.46%)  23/107 (21.50%)  6/61 (9.84%)  26/107 (24.30%) 
Cough  1  1/6 (16.67%)  0/8 (0.00%)  7/14 (50.00%)  2/10 (20.00%)  23/112 (20.54%)  14/107 (13.08%)  4/61 (6.56%)  15/107 (14.02%) 
Epistaxis  1  1/6 (16.67%)  0/8 (0.00%)  2/14 (14.29%)  0/10 (0.00%)  12/112 (10.71%)  12/107 (11.21%)  4/61 (6.56%)  16/107 (14.95%) 
Dyspnoea exertional  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  17/112 (15.18%)  9/107 (8.41%)  4/61 (6.56%)  12/107 (11.21%) 
Oropharyngeal pain  1  0/6 (0.00%)  1/8 (12.50%)  2/14 (14.29%)  1/10 (10.00%)  11/112 (9.82%)  4/107 (3.74%)  2/61 (3.28%)  5/107 (4.67%) 
Productive cough  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  10/112 (8.93%)  7/107 (6.54%)  1/61 (1.64%)  8/107 (7.48%) 
Dysphonia  1  1/6 (16.67%)  1/8 (12.50%)  0/14 (0.00%)  1/10 (10.00%)  7/112 (6.25%)  4/107 (3.74%)  3/61 (4.92%)  7/107 (6.54%) 
Rhinorrhoea  1  0/6 (0.00%)  1/8 (12.50%)  2/14 (14.29%)  2/10 (20.00%)  4/112 (3.57%)  3/107 (2.80%)  1/61 (1.64%)  4/107 (3.74%) 
Nasal congestion  1  2/6 (33.33%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  7/112 (6.25%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Pleural effusion  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  3/112 (2.68%)  2/107 (1.87%)  1/61 (1.64%)  3/107 (2.80%) 
Sinus congestion  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  2/112 (1.79%)  3/107 (2.80%)  1/61 (1.64%)  4/107 (3.74%) 
Rhinitis allergic  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  3/107 (2.80%)  0/61 (0.00%)  3/107 (2.80%) 
Upper-airway cough syndrome  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  2/112 (1.79%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Hiccups  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Sputum discoloured  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Skin and subcutaneous tissue disorders                 
Rash  1  0/6 (0.00%)  2/8 (25.00%)  3/14 (21.43%)  1/10 (10.00%)  18/112 (16.07%)  22/107 (20.56%)  2/61 (3.28%)  23/107 (21.50%) 
Hyperhidrosis  1  1/6 (16.67%)  2/8 (25.00%)  1/14 (7.14%)  2/10 (20.00%)  18/112 (16.07%)  4/107 (3.74%)  2/61 (3.28%)  6/107 (5.61%) 
Pruritus  1  0/6 (0.00%)  2/8 (25.00%)  1/14 (7.14%)  2/10 (20.00%)  8/112 (7.14%)  14/107 (13.08%)  1/61 (1.64%)  15/107 (14.02%) 
Dry skin  1  0/6 (0.00%)  0/8 (0.00%)  2/14 (14.29%)  0/10 (0.00%)  12/112 (10.71%)  9/107 (8.41%)  1/61 (1.64%)  10/107 (9.35%) 
Night sweats  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  14/112 (12.50%)  3/107 (2.80%)  2/61 (3.28%)  5/107 (4.67%) 
Alopecia  1  1/6 (16.67%)  0/8 (0.00%)  2/14 (14.29%)  2/10 (20.00%)  2/112 (1.79%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Ecchymosis  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  3/107 (2.80%)  3/61 (4.92%)  5/107 (4.67%) 
Petechiae  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  3/107 (2.80%)  0/61 (0.00%)  3/107 (2.80%) 
Urticaria  1  0/6 (0.00%)  2/8 (25.00%)  1/14 (7.14%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Cold sweat  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Nail disorder  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Pruritus allergic  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Rash erythematous  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Acne  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Drug eruption  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Hirsutism  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Ingrown nail  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Lichenoid karatosis  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Skin disorder  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Skin fissures  1  0/6 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Vascular disorders                 
Hypotension  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  6/112 (5.36%)  5/107 (4.67%)  1/61 (1.64%)  6/107 (5.61%) 
Hot flush  1  0/6 (0.00%)  1/8 (12.50%)  1/14 (7.14%)  0/10 (0.00%)  5/112 (4.46%)  3/107 (2.80%)  1/61 (1.64%)  4/107 (3.74%) 
Deep vein thrombosis  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Haematoma  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  1/107 (0.93%)  1/61 (1.64%)  2/107 (1.87%) 
Orthostatic hypotension  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  1/112 (0.89%)  1/107 (0.93%)  0/61 (0.00%)  1/107 (0.93%) 
Peripheral coldness  1  0/6 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/10 (0.00%)  1/112 (0.89%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Haemorrhage  1  0/6 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/10 (10.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Thrombosis  1  1/6 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/10 (0.00%)  0/112 (0.00%)  0/107 (0.00%)  0/61 (0.00%)  0/107 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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, and has priority over subset (single center) publication, for 1 year after study completion.
  • Investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. Celgene has 45 days to review and comment on draft manuscript/presentation, and may ask for an additional delay (not to exceed 90 days total) to address intellectual property issues.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00833833     History of Changes
Other Study ID Numbers: CC-4047-MM-002
First Submitted: January 30, 2009
First Posted: February 2, 2009
Results First Submitted: March 8, 2013
Results First Posted: April 25, 2013
Last Update Posted: April 27, 2016