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Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01482884
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
MedImmune Ltd
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: tralokinumab
Drug: placebo
Enrollment 147

Recruitment Details 147/111 patients were enrolled/randomized from 31 centres in 6 European countries. The first patient was enrolled on 26 March 2012, and the last patient completed the study on 24 June 2013.
Pre-assignment Details Participants were enrolled for a period of 3 weeks.
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2. Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Period Title: Overall Study
Started 56 [1] 55
Completed 43 37
Not Completed 13 18
Reason Not Completed
Medical decision due to lack of efficacy             0             1
Protocol Violation             1             0
Lost to Follow-up             2             2
Lack of Efficacy             0             1
Adverse Event             2             1
Withdrawal by Subject             8             13
[1]
One participant did not receive study treatment
Arm/Group Title Tralokinumab Placebo Total
Hide Arm/Group Description Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2. Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2. Total of all reporting groups
Overall Number of Baseline Participants 56 55 111
Hide Baseline Analysis Population Description
All randomised participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 55 participants 111 participants
42.2  (11.54) 40.8  (13.26) 41.5  (12.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Female
29
  51.8%
29
  52.7%
58
  52.3%
Male
27
  48.2%
26
  47.3%
53
  47.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Asian 2 0 2
White 54 54 108
Other 0 1 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Hispanic or Latino 2 2 4
Asian (Other than Chinese And Japanese) 2 0 2
Not Applicable 35 40 75
Other 17 13 30
Duration of disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 55 participants 111 participants
9.22  (8.523) 7.78  (8.664) 8.51  (8.585)
Mayo score at baseline   [1] 
Mean (Full Range)
Unit of measure:  Scores on scale
Number Analyzed 56 participants 55 participants 111 participants
8.36
(5.0 to 11.0)
8.33
(6.0 to 11.0)
8.34
(5.0 to 11.0)
[1]
Measure Description: Mayo score is the sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
Partial Mayo score at baseline   [1] 
Mean (Full Range)
Unit of measure:  Scores on scale
Number Analyzed 56 participants 55 participants 111 participants
5.91
(3.0 to 8.0)
5.85
(3.0 to 8.0)
5.88
(3.0 to 8.0)
[1]
Measure Description: The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician’s global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease.
Glucocorticosteroid-refractory status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Yes 3 8 11
No 53 46 99
Unknown 0 1 1
[1]
Measure Description: Yes: if participants had received a glucocorticosteroid treatment prior to baseline and the outcome of that treatment was no improvement. No: If the outcome of the treatment was improvement or missing. Unknown: If the outcome of the treatment was unknown.
1.Primary Outcome
Title Clinical Response at Week 8 Based on Mayo Score
Hide Description Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
Time Frame Eight week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of responders
37.5 32.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tralokinumab, Placebo
Comments The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4062
Comments Glucocorticosteroid-refractory status as stratification factor
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-13.0 to 22.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Mayo Score From Baseline to Week 8
Hide Description Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.
Time Frame Eight week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 45 42
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
-2.41  (0.58) -1.92  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tralokinumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3937
Comments [Not Specified]
Method ANCOVA
Comments Mayo score at baseline as a covariate, and treatment and glucocorticosteroid-refractory status as factors in the model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-1.63 to 0.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mucosal Healing at Week 8 Based on Mayo Score
Hide Description Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.
Time Frame Eight week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of participants
32.1 20.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tralokinumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1043
Comments Glucocorticosteroid-refractory status as stratification factor
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.1
Confidence Interval (2-Sided) 95%
-4.0 to 28.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Clinical Remission at Week 8 Based on Mayo Score
Hide Description Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
Time Frame Eight week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: Percentage of participants
17.9 5.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tralokinumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0326
Comments Glucocorticosteroid-refractory status as stratification factor
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.4
Confidence Interval (2-Sided) 95%
0.7 to 24.1
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Partial Mayo Score
Hide Description The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician’s global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.
Time Frame From baseline to Week 4, 8, 12, 16, 20, and 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 56 55
Mean (Full Range)
Unit of Measure: Score on scale
Week 4
-1.8
(-8 to 3)
-0.8
(-6 to 4)
Week 8
-2.4
(-6 to 3)
-1.7
(-6 to 1)
Week 12
-2.7
(-7 to 3)
-2.6
(-8 to 4)
Week 16
-2.6
(-7 to 3)
-3.3
(-7 to 2)
Week 20
-3.0
(-7 to 2)
-3.6
(-8 to 1)
Week 24
-3.0
(-7 to 3)
-3.6
(-7 to 1)
6.Secondary Outcome
Title Change From Baseline in Modified Riley Score
Hide Description Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.
Time Frame Eight week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 37 35
Least Squares Mean (Standard Error)
Unit of Measure: Grade on scale
-0.49  (0.23) -0.74  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tralokinumab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4490
Comments [Not Specified]
Method ANCOVA
Comments Modified Riley score at baseline as a covariate, and treatment as factors in the model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.41 to 0.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.33
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in C - Reactive Protein
Hide Description [Not Specified]
Time Frame From baseline to Week 4, 8, 12, 16, 20, and 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 56 55
Mean (Full Range)
Unit of Measure: mg/L
Week 4
-2.755
(-33.00 to 25.00)
0.510
(-12.00 to 32.00)
Week 8
-1.089
(-29.00 to 29.00)
0.637
(-43.00 to 46.00)
Week 12
-2.795
(-46.00 to 63.00)
-1.974
(-61.00 to 43.00)
Week 16
-3.490
(-53.00 to 19.00)
0.638
(-61.00 to 97.00)
Week 20
-4.094
(-52.00 to 43.00)
-1.467
(-62.00 to 31.00)
Week 24
-2.754
(-36.00 to 25.00)
-1.915
(-59.00 to 36.00)
8.Secondary Outcome
Title Change From Baseline in Albumin
Hide Description [Not Specified]
Time Frame From baseline to Week 4, 8, 12, 16, 20, and 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 56 55
Mean (Full Range)
Unit of Measure: g/L
Week 4
0.0
(-8 to 5)
-0.7
(-7 to 6)
Week 8
0.8
(-7 to 8)
-0.2
(-8 to 5)
Week 12
0.3
(-9 to 5)
-0.4
(-8 to 5)
Week 16
0.5
(-10 to 12)
0.4
(-7 to 7)
Week 20
1.1
(-4 to 7)
0.1
(-6 to 9)
Week 24
1.2
(-4 to 8)
0.2
(-6 to 8)
9.Secondary Outcome
Title Change From Baseline in Calprotectin
Hide Description [Not Specified]
Time Frame From baseline to Week 4, 8, 12, 16, 20, and 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set consist of all randomised participants
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 56 55
Mean (Full Range)
Unit of Measure: ug/g
Week 4
69.45
(-1068.0 to 931.0)
198.80
(-1315.0 to 4188.0)
Week 8
86.47
(-894.2 to 912.0)
-250.52
(-4005.0 to 4505.0)
Week 12
-39.19
(-1109.0 to 841.0)
50.31
(-1234.0 to 4811.0)
Week 16
-75.10
(-1008.0 to 1056.0)
-338.76
(-3857.0 to 1138.0)
Week 20
32.55
(-1155.0 to 4669.0)
-402.81
(-3835.0 to 794.0)
Week 24
-136.78
(-1120.0 to 617.0)
-267.58
(-1172.0 to 824.0)
10.Secondary Outcome
Title Serum Concentration of Tralokinumab
Hide Description [Not Specified]
Time Frame Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consist of all randomised participants who received at least one dose of study medication.
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 55 55
Mean (Full Range)
Unit of Measure: ug/ml
pre-dose at baseline
0.00
(0.000 to 0.000)
NA [1] 
(NA to NA)
Week 4
37.9
(12.2 to 92.2)
NA [1] 
(NA to NA)
Week 8
50.2
(5.83 to 116)
NA [1] 
(NA to NA)
Week 12
48.2
(0.781 to 109)
NA [2] 
(NA to NA)
Week 16
27.2
(0.369 to 82.7)
NA [1] 
(NA to NA)
Week 20
9.32
(0.527 to 36.9)
NA [1] 
(NA to NA)
Week 24
3.66
(0.000 to 18.0)
NA [1] 
(NA to NA)
[1]
Not calculable because below the lower limit of quantification
[2]

There are only two concentration results available for Placebo Patients specified in the listing:

Day 85 - 0,658 - below LLOQ Day 89 - 5.93 - above LLOQ

11.Secondary Outcome
Title Immunogenicity
Hide Description Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.
Time Frame Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consist of all randomised participants who received at least one dose of study medication.
Arm/Group Title Tralokinumab Placebo
Hide Arm/Group Description:
Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Number of Participants Analyzed 55 55
Measure Type: Number
Unit of Measure: participants
pre-dose at baseline 0 1
Week 8 0 1
Week 12 0 1
Week 16 0 1
Week 24 0 0
Time Frame 24 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tralokinumab 300 mg
Hide Arm/Group Description Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2. Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
All-Cause Mortality
Placebo Tralokinumab 300 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tralokinumab 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/55 (10.91%)      7/55 (12.73%)    
Blood and lymphatic system disorders     
ANAEMIA  1  1/55 (1.82%)  1 1/55 (1.82%)  2
Gastrointestinal disorders     
COLITIS ULCERATIVE  1  5/55 (9.09%)  6 5/55 (9.09%)  5
General disorders     
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Immune system disorders     
SERUM SICKNESS  1  0/55 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders     
CEREBROVASCULAR ACCIDENT  1  1/55 (1.82%)  1 0/55 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Tralokinumab 300 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/55 (63.64%)      36/55 (65.45%)    
Blood and lymphatic system disorders     
ANAEMIA  1  1/55 (1.82%)  1 3/55 (5.45%)  3
Cardiac disorders     
TACHYCARDIA  1  2/55 (3.64%)  2 2/55 (3.64%)  2
Gastrointestinal disorders     
ABDOMINAL PAIN  1  6/55 (10.91%)  9 7/55 (12.73%)  13
COLITIS ULCERATIVE  1  10/55 (18.18%)  12 11/55 (20.00%)  13
HAEMORRHOIDS  1  1/55 (1.82%)  1 3/55 (5.45%)  3
TOOTHACHE  1  1/55 (1.82%)  1 3/55 (5.45%)  3
ABDOMINAL DISCOMFORT  1  0/55 (0.00%)  0 2/55 (3.64%)  2
ABDOMINAL TENDERNESS  1  1/55 (1.82%)  1 2/55 (3.64%)  2
DIARRHOEA  1  0/55 (0.00%)  0 2/55 (3.64%)  2
DYSPEPSIA  1  2/55 (3.64%)  2 2/55 (3.64%)  2
NAUSEA  1  2/55 (3.64%)  2 2/55 (3.64%)  10
VOMITING  1  2/55 (3.64%)  2 2/55 (3.64%)  3
General disorders     
ASTHENIA  1  5/55 (9.09%)  6 5/55 (9.09%)  5
FATIGUE  1  2/55 (3.64%)  2 3/55 (5.45%)  3
INJECTION SITE ERYTHEMA  1  0/55 (0.00%)  0 3/55 (5.45%)  10
INJECTION SITE REACTION  1  0/55 (0.00%)  0 3/55 (5.45%)  3
PYREXIA  1  4/55 (7.27%)  4 6/55 (10.91%)  7
INFLUENZA LIKE ILLNESS  1  2/55 (3.64%)  3 0/55 (0.00%)  0
Infections and infestations     
INFLUENZA  1  4/55 (7.27%)  5 2/55 (3.64%)  2
NASOPHARYNGITIS  1  5/55 (9.09%)  6 3/55 (5.45%)  3
PHARYNGITIS  1  2/55 (3.64%)  3 2/55 (3.64%)  2
SINUSITIS  1  2/55 (3.64%)  2 1/55 (1.82%)  1
Investigations     
WEIGHT DECREASED  1  0/55 (0.00%)  0 3/55 (5.45%)  3
Metabolism and nutrition disorders     
DECREASED APPETITE  1  0/55 (0.00%)  0 3/55 (5.45%)  3
VITAMIN D DEFICIENCY  1  2/55 (3.64%)  2 0/55 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  7/55 (12.73%)  7 3/55 (5.45%)  3
BACK PAIN  1  4/55 (7.27%)  5 3/55 (5.45%)  5
MUSCLE SPASMS  1  2/55 (3.64%)  2 0/55 (0.00%)  0
MYALGIA  1  2/55 (3.64%)  2 1/55 (1.82%)  1
PAIN IN EXTREMITY  1  2/55 (3.64%)  2 1/55 (1.82%)  1
Nervous system disorders     
HEADACHE  1  12/55 (21.82%)  22 10/55 (18.18%)  35
DIZZINESS  1  2/55 (3.64%)  2 2/55 (3.64%)  2
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  0/55 (0.00%)  0 3/55 (5.45%)  3
OROPHARYNGEAL PAIN  1  2/55 (3.64%)  2 4/55 (7.27%)  5
COUGH  1  2/55 (3.64%)  2 2/55 (3.64%)  2
Skin and subcutaneous tissue disorders     
ALOPECIA  1  2/55 (3.64%)  2 3/55 (5.45%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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.
Results Point of Contact
Name/Title: Mark Berner Hansen
Organization: AstraZeneca
Phone: +46 31 776 4794
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01482884     History of Changes
Other Study ID Numbers: D2211C00001
EudraCT number 2011-004812-40
First Submitted: November 29, 2011
First Posted: December 1, 2011
Results First Submitted: January 20, 2015
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016