Trial Outcomes & Findings for Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (NCT NCT03328897)

Last Updated: 2020-11-04

Results Overview

The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

418 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2020-11-04

Participant Flow

Patients were recruited from 27 sites across China.

Patients were randomized into three treatment groups (omalizumab 300 mg s.c., omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio.

Participant milestones

Participant milestones
Measure	Omalizumab 300mg patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Randomized-treatment Epoch STARTED	168	167	83
Randomized-treatment Epoch Full Analysis Set (FAS)	167	167	83
Randomized-treatment Epoch COMPLETED	152	162	81
Randomized-treatment Epoch NOT COMPLETED	16	5	2
Follow-up Epoch STARTED	161	163	81
Follow-up Epoch COMPLETED	153	160	79
Follow-up Epoch NOT COMPLETED	8	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Omalizumab 300mg patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Randomized-treatment Epoch Adverse Event	4	1	1
Randomized-treatment Epoch Lost to Follow-up	0	1	0
Randomized-treatment Epoch Pregnancy	3	0	0
Randomized-treatment Epoch Patient/guardian decision	8	3	1
Randomized-treatment Epoch Lack of Efficacy	1	0	0
Follow-up Epoch Adverse Event	4	0	1
Follow-up Epoch Lack of Efficacy	1	1	1
Follow-up Epoch Lost to Follow-up	0	1	0
Follow-up Epoch Pregnancy	1	0	0
Follow-up Epoch Patient/guardian decision	2	1	0

Baseline Characteristics

Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab 300mg n=168 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Total n=418 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 12.29 • n=5 Participants	38.8 years STANDARD_DEVIATION 12.18 • n=7 Participants	42.8 years STANDARD_DEVIATION 12.32 • n=5 Participants	40.2 years STANDARD_DEVIATION 12.31 • n=4 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	108 Participants n=7 Participants	53 Participants n=5 Participants	276 Participants n=4 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	59 Participants n=7 Participants	30 Participants n=5 Participants	142 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	168 Participants n=5 Participants	167 Participants n=7 Participants	83 Participants n=5 Participants	418 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Chinese	168 Participants n=5 Participants	167 Participants n=7 Participants	83 Participants n=5 Participants	418 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment	-10.11 Score on a scale Standard Error 0.430	-9.66 Score on a scale Standard Error 0.424	-5.87 Score on a scale Standard Error 0.604

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment	-21.82 Score on a scale Standard Error 0.895	-20.74 Score on a scale Standard Error 0.882	-11.62 Score on a scale Standard Error 1.258

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set

Hives Severity Score (HSS), defined by number of hives, were recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly number of hives score (NHS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21. The complete hives response was defined as NHS7 = 0. Hives Severity Score scale: 0 - None * Mild (1-6 hives/12 hours) * Moderate (7-12 hives/12 hours) * Severe (\>12 hives/12 hours)

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment	-11.68 Score on a scale Standard Error 0.492	-11.11 Score on a scale Standard Error 0.485	-5.76 Score on a scale Standard Error 0.690

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set

UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Week 12 responders were defined as patients who achieved an absolute UAS7 ≤ 6 at Week 12. A patient with missing data at Week 12 was imputed as a responder if the patient was a responder at Week 10 and Week 11, otherwise as a non-responder.

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Percentage of Patients With UAS7≤6 at Week 12	81 Participants	79 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Percentage of Complete Responders (UAS7 = 0) at Week 12	62 Participants	39 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12	125 Participants	125 Participants	49 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Full analysis set

Dermatology life quality index (DLQI) is a 10-item dermatology- specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as separate scores for the following domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment. Each domain had 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment	-10.4 Score on a scale Standard Error 0.50	-9.9 Score on a scale Standard Error 0.49	-6.5 Score on a scale Standard Error 0.69

SECONDARY outcome

Timeframe: 12 weeks

Population: Full analysis set

The ISS7 MID response was defined as a reduction from Baseline in ISS7 of ≥ 5 points. Time to ISS7 MID response was the time (in weeks) from the date of the first dose to the date where ISS7 MID response was first achieved during Week 1 to Week 12.

Outcome measures

Outcome measures
Measure	Omalizumab 300mg n=167 Participants patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)	Omalizumab 150mg n=167 Participants patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8)	Placebo n=83 Participants patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Time to ISS7 MID Response by Week 12 No response	25 Participants	23 Participants	24 Participants
Time to ISS7 MID Response by Week 12 First Response: >0 to <=4 weeks	114 Participants	109 Participants	42 Participants
Time to ISS7 MID Response by Week 12 First Response: >4 to <=8 weeks	18 Participants	25 Participants	10 Participants
Time to ISS7 MID Response by Week 12 First Response: >8 to <=12 weeks	10 Participants	10 Participants	7 Participants

Adverse Events

Omalizumab 300 mg

Serious events: 5 serious events

Other events: 84 other events

Deaths: 0 deaths

Omalizumab 150 mg

Serious events: 5 serious events

Other events: 79 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omalizumab 300 mg n=167 participants at risk Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.	Omalizumab 150 mg n=167 participants at risk Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.	Placebo n=83 participants at risk patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Ear and labyrinth disorders Vertigo positional	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Pelvic inflammatory disease	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Upper respiratory tract infection	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Pregnancy, puerperium and perinatal conditions Pregnancy	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Reproductive system and breast disorders Rectocele	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Skin and subcutaneous tissue disorders Urticaria chronic	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Vascular disorders Embolism venous	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Vascular disorders Hypertension	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Omalizumab 300 mg n=167 participants at risk Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.	Omalizumab 150 mg n=167 participants at risk Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.	Placebo n=83 participants at risk patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Gastrointestinal disorders Diarrhoea	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
General disorders Pyrexia	3.0% 5/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	3.6% 3/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Herpes zoster	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Influenza	4.2% 7/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	4.2% 7/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Nasopharyngitis	4.2% 7/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	4.8% 8/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	8.4% 7/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Pharyngitis	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	3.6% 3/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Upper respiratory tract infection	21.6% 36/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	15.0% 25/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	14.5% 12/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Infections and infestations Urinary tract infection	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Investigations Alanine aminotransferase increased	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	3.6% 6/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Investigations Blood creatine phosphokinase increased	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	3.0% 5/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Investigations Blood glucose increased	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Investigations Blood uric acid increased	3.0% 5/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	3.0% 5/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	4.8% 4/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Investigations Lymphocyte count increased	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Investigations Platelet count decreased	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Investigations Red blood cells urine positive	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Metabolism and nutrition disorders Hyperuricaemia	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.8% 3/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Musculoskeletal and connective tissue disorders Arthralgia	3.6% 6/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Musculoskeletal and connective tissue disorders Back pain	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Nervous system disorders Dizziness	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Nervous system disorders Headache	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Nervous system disorders Hypoaesthesia	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Respiratory, thoracic and mediastinal disorders Cough	6.6% 11/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.8% 3/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 2/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	3.6% 3/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Skin and subcutaneous tissue disorders Dermatitis	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.60% 1/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	3.6% 3/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Skin and subcutaneous tissue disorders Eczema	3.0% 5/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 1/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).
Vascular disorders Hypertension	2.4% 4/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	1.2% 2/167 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).	0.00% 0/83 • Adverse events were collected from first dose of study treatment until end of study treatment (Day 1 to week 12) plus 8 weeks post-treatment follow-up epoch (week 12 to week 20).