Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis (NCT NCT01482884)

Last Updated: 2016-04-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

147 participants

Primary outcome timeframe

Eight week treatment period

Results posted on

2016-04-05

Participant Flow

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.

Participants were enrolled for a period of 3 weeks.

Participant milestones

Participant milestones
Measure	Tralokinumab Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Study STARTED	56	55
Overall Study COMPLETED	43	37
Overall Study NOT COMPLETED	13	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Tralokinumab Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Overall Study Medical decision due to lack of efficacy	0	1
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	2	2
Overall Study Lack of Efficacy	0	1
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	8	13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.	Total n=111 Participants Total of all reporting groups
Age, Continuous	42.2 Years STANDARD_DEVIATION 11.54 • n=99 Participants	40.8 Years STANDARD_DEVIATION 13.26 • n=107 Participants	41.5 Years STANDARD_DEVIATION 12.39 • n=206 Participants
Sex: Female, Male Female	29 Participants n=99 Participants	29 Participants n=107 Participants	58 Participants n=206 Participants
Sex: Female, Male Male	27 Participants n=99 Participants	26 Participants n=107 Participants	53 Participants n=206 Participants
Race/Ethnicity, Customized Asian	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized White	54 Participants n=99 Participants	54 Participants n=107 Participants	108 Participants n=206 Participants
Race/Ethnicity, Customized Other	17 Participants n=99 Participants	13 Participants n=107 Participants	30 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race/Ethnicity, Customized Asian (Other than Chinese And Japanese)	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized Not Applicable	35 Participants n=99 Participants	40 Participants n=107 Participants	75 Participants n=206 Participants
Duration of disease	9.22 Years STANDARD_DEVIATION 8.523 • n=99 Participants	7.78 Years STANDARD_DEVIATION 8.664 • n=107 Participants	8.51 Years STANDARD_DEVIATION 8.585 • n=206 Participants
Mayo score at baseline	8.36 Scores on scale n=99 Participants	8.33 Scores on scale n=107 Participants	8.34 Scores on scale n=206 Participants
Partial Mayo score at baseline	5.91 Scores on scale n=99 Participants	5.85 Scores on scale n=107 Participants	5.88 Scores on scale n=206 Participants
Glucocorticosteroid-refractory status Yes	3 Participants n=99 Participants	8 Participants n=107 Participants	11 Participants n=206 Participants
Glucocorticosteroid-refractory status No	53 Participants n=99 Participants	46 Participants n=107 Participants	99 Participants n=206 Participants
Glucocorticosteroid-refractory status Unknown	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: Eight week treatment period

Population: The full analysis set consist of all randomised participants

Outcome measures

Outcome measures
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Clinical Response at Week 8 Based on Mayo Score	37.5 Percentage of responders	32.7 Percentage of responders

SECONDARY outcome

Timeframe: Eight week treatment period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab n=45 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=42 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Change in Mayo Score From Baseline to Week 8	-2.41 Score on scale Standard Error 0.58	-1.92 Score on scale Standard Error 0.56

SECONDARY outcome

Timeframe: Eight week treatment period

Population: The full analysis set consist of all randomised participants

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.

Outcome measures

Outcome measures
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Mucosal Healing at Week 8 Based on Mayo Score	32.1 Percentage of participants	20.0 Percentage of participants

SECONDARY outcome

Timeframe: Eight week treatment period

Population: The full analysis set consist of all randomised participants

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.

Outcome measures

Outcome measures
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Clinical Remission at Week 8 Based on Mayo Score	17.9 Percentage of participants	5.5 Percentage of participants

SECONDARY outcome

Timeframe: From baseline to Week 4, 8, 12, 16, 20, and 24.

Population: The full analysis set consist of all randomised participants

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.

Outcome measures

Outcome measures
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Change From Baseline in Partial Mayo Score Week 16	-2.6 Score on scale Full Range 0.34 • Interval -7.0 to 3.0	-3.3 Score on scale Full Range 0.37 • Interval -7.0 to 2.0
Change From Baseline in Partial Mayo Score Week 20	-3.0 Score on scale Full Range 0.33 • Interval -7.0 to 2.0	-3.6 Score on scale Full Range 0.37 • Interval -8.0 to 1.0
Change From Baseline in Partial Mayo Score Week 4	-1.8 Score on scale Full Range 0.31 • Interval -8.0 to 3.0	-0.8 Score on scale Full Range 0.31 • Interval -6.0 to 4.0
Change From Baseline in Partial Mayo Score Week 8	-2.4 Score on scale Full Range 0.29 • Interval -6.0 to 3.0	-1.7 Score on scale Full Range 0.30 • Interval -6.0 to 1.0
Change From Baseline in Partial Mayo Score Week 12	-2.7 Score on scale Full Range 0.34 • Interval -7.0 to 3.0	-2.6 Score on scale Full Range 0.36 • Interval -8.0 to 4.0
Change From Baseline in Partial Mayo Score Week 24	-3.0 Score on scale Full Range 0.35 • Interval -7.0 to 3.0	-3.6 Score on scale Full Range 0.38 • Interval -7.0 to 1.0

SECONDARY outcome

Timeframe: Eight week treatment period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tralokinumab n=37 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=35 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Change From Baseline in Modified Riley Score	-0.49 Grade on scale Standard Error 0.23	-0.74 Grade on scale Standard Error 0.24

SECONDARY outcome

Timeframe: From baseline to Week 4, 8, 12, 16, 20, and 24.

Population: The full analysis set consist of all randomised participants

Outcome measures

Outcome measures
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Change From Baseline in C - Reactive Protein Week 4	-2.755 mg/L Full Range 0.31 • Interval -33.0 to 25.0	0.510 mg/L Full Range 0.31 • Interval -12.0 to 32.0
Change From Baseline in C - Reactive Protein Week 8	-1.089 mg/L Full Range 0.29 • Interval -29.0 to 29.0	0.637 mg/L Full Range 0.30 • Interval -43.0 to 46.0
Change From Baseline in C - Reactive Protein Week 12	-2.795 mg/L Full Range 0.34 • Interval -46.0 to 63.0	-1.974 mg/L Full Range 0.36 • Interval -61.0 to 43.0
Change From Baseline in C - Reactive Protein Week 16	-3.490 mg/L Full Range 0.34 • Interval -53.0 to 19.0	0.638 mg/L Full Range 0.37 • Interval -61.0 to 97.0
Change From Baseline in C - Reactive Protein Week 20	-4.094 mg/L Full Range 0.33 • Interval -52.0 to 43.0	-1.467 mg/L Full Range 0.37 • Interval -62.0 to 31.0
Change From Baseline in C - Reactive Protein Week 24	-2.754 mg/L Full Range 0.35 • Interval -36.0 to 25.0	-1.915 mg/L Full Range 0.38 • Interval -59.0 to 36.0

SECONDARY outcome

Timeframe: From baseline to Week 4, 8, 12, 16, 20, and 24.

Population: The full analysis set consist of all randomised participants

Outcome measures

Outcome measures
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Change From Baseline in Albumin Week 4	0.0 g/L Full Range 0.31 • Interval -8.0 to 5.0	-0.7 g/L Full Range 0.31 • Interval -7.0 to 6.0
Change From Baseline in Albumin Week 8	0.8 g/L Full Range 0.29 • Interval -7.0 to 8.0	-0.2 g/L Full Range 0.30 • Interval -8.0 to 5.0
Change From Baseline in Albumin Week 12	0.3 g/L Full Range 0.34 • Interval -9.0 to 5.0	-0.4 g/L Full Range 0.36 • Interval -8.0 to 5.0
Change From Baseline in Albumin Week 16	0.5 g/L Full Range 0.34 • Interval -10.0 to 12.0	0.4 g/L Full Range 0.37 • Interval -7.0 to 7.0
Change From Baseline in Albumin Week 20	1.1 g/L Full Range 0.33 • Interval -4.0 to 7.0	0.1 g/L Full Range 0.37 • Interval -6.0 to 9.0
Change From Baseline in Albumin Week 24	1.2 g/L Full Range 0.35 • Interval -4.0 to 8.0	0.2 g/L Full Range 0.38 • Interval -6.0 to 8.0

SECONDARY outcome

Timeframe: From baseline to Week 4, 8, 12, 16, 20, and 24.

Population: The full analysis set consist of all randomised participants

Outcome measures

Outcome measures
Measure	Tralokinumab n=56 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Change From Baseline in Calprotectin Week 4	69.45 ug/g Full Range 0.31 • Interval -1068.0 to 931.0	198.80 ug/g Full Range 0.31 • Interval -1315.0 to 4188.0
Change From Baseline in Calprotectin Week 8	86.47 ug/g Full Range 0.29 • Interval -894.2 to 912.0	-250.52 ug/g Full Range 0.30 • Interval -4005.0 to 4505.0
Change From Baseline in Calprotectin Week 12	-39.19 ug/g Full Range 0.34 • Interval -1109.0 to 841.0	50.31 ug/g Full Range 0.36 • Interval -1234.0 to 4811.0
Change From Baseline in Calprotectin Week 16	-75.10 ug/g Full Range 0.34 • Interval -1008.0 to 1056.0	-338.76 ug/g Full Range 0.37 • Interval -3857.0 to 1138.0
Change From Baseline in Calprotectin Week 20	32.55 ug/g Full Range 0.33 • Interval -1155.0 to 4669.0	-402.81 ug/g Full Range 0.37 • Interval -3835.0 to 794.0
Change From Baseline in Calprotectin Week 24	-136.78 ug/g Full Range 0.35 • Interval -1120.0 to 617.0	-267.58 ug/g Full Range 0.38 • Interval -1172.0 to 824.0

SECONDARY outcome

Timeframe: Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.

Population: The safety analysis set consist of all randomised participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Tralokinumab n=55 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Serum Concentration of Tralokinumab Week 24	3.66 ug/ml Interval 0.0 to 18.0	NA ug/ml Not calculable because below the lower limit of quantification
Serum Concentration of Tralokinumab pre-dose at baseline	0.00 ug/ml Full Range 0.31 • Interval 0.0 to 0.0	NA ug/ml Not calculable because below the lower limit of quantification
Serum Concentration of Tralokinumab Week 4	37.9 ug/ml Full Range 0.29 • Interval 12.2 to 92.2	NA ug/ml Not calculable because below the lower limit of quantification
Serum Concentration of Tralokinumab Week 8	50.2 ug/ml Full Range 0.34 • Interval 5.83 to 116.0	NA ug/ml Not calculable because below the lower limit of quantification
Serum Concentration of Tralokinumab Week 12	48.2 ug/ml Full Range 0.34 • Interval 0.781 to 109.0	NA ug/ml 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
Serum Concentration of Tralokinumab Week 16	27.2 ug/ml Full Range 0.33 • Interval 0.369 to 82.7	NA ug/ml Not calculable because below the lower limit of quantification
Serum Concentration of Tralokinumab Week 20	9.32 ug/ml Full Range 0.35 • Interval 0.527 to 36.9	NA ug/ml Not calculable because below the lower limit of quantification

SECONDARY outcome

Timeframe: Pre-dose sampling at baseline, Week 8, 12, 16, and 24.

Population: The safety analysis set consist of all randomised participants who received at least one dose of study medication.

Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.

Outcome measures

Outcome measures
Measure	Tralokinumab n=55 Participants Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.	Placebo n=55 Participants Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
Immunogenicity pre-dose at baseline	0 participants 0.31 • Interval 0.0 to 0.0	1 participants
Immunogenicity Week 8	0 participants 0.29 • Interval 12.2 to 92.2	1 participants
Immunogenicity Week 12	0 participants 0.34 • Interval 5.83 to 116.0	1 participants
Immunogenicity Week 16	0 participants 0.34 • Interval 0.781 to 109.0	1 participants
Immunogenicity Week 24	0 participants 0.33 • Interval 0.369 to 82.7	0 participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

Tralokinumab 300 mg

Serious events: 7 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=55 participants at risk Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.	Tralokinumab 300 mg n=55 participants at risk Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Blood and lymphatic system disorders ANAEMIA	1.8% 1/55 • Number of events 1 • 24 Weeks	1.8% 1/55 • Number of events 2 • 24 Weeks
Gastrointestinal disorders COLITIS ULCERATIVE	9.1% 5/55 • Number of events 6 • 24 Weeks	9.1% 5/55 • Number of events 5 • 24 Weeks
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	1.8% 1/55 • Number of events 1 • 24 Weeks	0.00% 0/55 • 24 Weeks
Immune system disorders SERUM SICKNESS	0.00% 0/55 • 24 Weeks	1.8% 1/55 • Number of events 1 • 24 Weeks
Nervous system disorders CEREBROVASCULAR ACCIDENT	1.8% 1/55 • Number of events 1 • 24 Weeks	0.00% 0/55 • 24 Weeks

Other adverse events

Other adverse events
Measure	Placebo n=55 participants at risk Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.	Tralokinumab 300 mg n=55 participants at risk Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
Gastrointestinal disorders ABDOMINAL TENDERNESS	1.8% 1/55 • Number of events 1 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Gastrointestinal disorders DIARRHOEA	0.00% 0/55 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Gastrointestinal disorders DYSPEPSIA	3.6% 2/55 • Number of events 2 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Gastrointestinal disorders NAUSEA	3.6% 2/55 • Number of events 2 • 24 Weeks	3.6% 2/55 • Number of events 10 • 24 Weeks
Gastrointestinal disorders VOMITING	3.6% 2/55 • Number of events 2 • 24 Weeks	3.6% 2/55 • Number of events 3 • 24 Weeks
General disorders INFLUENZA LIKE ILLNESS	3.6% 2/55 • Number of events 3 • 24 Weeks	0.00% 0/55 • 24 Weeks
Infections and infestations PHARYNGITIS	3.6% 2/55 • Number of events 3 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Infections and infestations SINUSITIS	3.6% 2/55 • Number of events 2 • 24 Weeks	1.8% 1/55 • Number of events 1 • 24 Weeks
Blood and lymphatic system disorders ANAEMIA	1.8% 1/55 • Number of events 1 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
Gastrointestinal disorders ABDOMINAL PAIN	10.9% 6/55 • Number of events 9 • 24 Weeks	12.7% 7/55 • Number of events 13 • 24 Weeks
Gastrointestinal disorders COLITIS ULCERATIVE	18.2% 10/55 • Number of events 12 • 24 Weeks	20.0% 11/55 • Number of events 13 • 24 Weeks
Gastrointestinal disorders HAEMORRHOIDS	1.8% 1/55 • Number of events 1 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
Gastrointestinal disorders TOOTHACHE	1.8% 1/55 • Number of events 1 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
General disorders ASTHENIA	9.1% 5/55 • Number of events 6 • 24 Weeks	9.1% 5/55 • Number of events 5 • 24 Weeks
General disorders FATIGUE	3.6% 2/55 • Number of events 2 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
General disorders INJECTION SITE ERYTHEMA	0.00% 0/55 • 24 Weeks	5.5% 3/55 • Number of events 10 • 24 Weeks
General disorders INJECTION SITE REACTION	0.00% 0/55 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
General disorders PYREXIA	7.3% 4/55 • Number of events 4 • 24 Weeks	10.9% 6/55 • Number of events 7 • 24 Weeks
Infections and infestations INFLUENZA	7.3% 4/55 • Number of events 5 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Infections and infestations NASOPHARYNGITIS	9.1% 5/55 • Number of events 6 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
Investigations WEIGHT DECREASED	0.00% 0/55 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/55 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
Musculoskeletal and connective tissue disorders ARTHRALGIA	12.7% 7/55 • Number of events 7 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
Musculoskeletal and connective tissue disorders BACK PAIN	7.3% 4/55 • Number of events 5 • 24 Weeks	5.5% 3/55 • Number of events 5 • 24 Weeks
Nervous system disorders HEADACHE	21.8% 12/55 • Number of events 22 • 24 Weeks	18.2% 10/55 • Number of events 35 • 24 Weeks
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/55 • 24 Weeks	5.5% 3/55 • Number of events 3 • 24 Weeks
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	3.6% 2/55 • Number of events 2 • 24 Weeks	7.3% 4/55 • Number of events 5 • 24 Weeks
Skin and subcutaneous tissue disorders ALOPECIA	3.6% 2/55 • Number of events 2 • 24 Weeks	5.5% 3/55 • Number of events 4 • 24 Weeks
Cardiac disorders TACHYCARDIA	3.6% 2/55 • Number of events 2 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/55 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	3.6% 2/55 • Number of events 2 • 24 Weeks	0.00% 0/55 • 24 Weeks
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	3.6% 2/55 • Number of events 2 • 24 Weeks	0.00% 0/55 • 24 Weeks
Musculoskeletal and connective tissue disorders MYALGIA	3.6% 2/55 • Number of events 2 • 24 Weeks	1.8% 1/55 • Number of events 1 • 24 Weeks
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	3.6% 2/55 • Number of events 2 • 24 Weeks	1.8% 1/55 • Number of events 1 • 24 Weeks
Nervous system disorders DIZZINESS	3.6% 2/55 • Number of events 2 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks
Respiratory, thoracic and mediastinal disorders COUGH	3.6% 2/55 • Number of events 2 • 24 Weeks	3.6% 2/55 • Number of events 2 • 24 Weeks

Additional Information

Mark Berner Hansen

AstraZeneca

Phone: +46 31 776 4794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60