Trial Outcomes & Findings for LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris (NCT NCT02132936)
NCT ID: NCT02132936
Last Updated: 2025-03-10
Results Overview
To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
504 participants
Primary outcome timeframe
4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel
Results posted on
2025-03-10
Participant Flow
First Subject First Visit: 30-Jun-2014 Last Subject Last Visit: 04-Mar-2015
A total of 504 subjects were enrolled, 41 enrolled subjects were not randomised. 463 subjects were randomised as follows: 185 subjects to LEO 90100, 188 to calcipotriol BDP gel, 47 to foam vehicle, and 43 to gel vehicle
Participant milestones
| Measure |
LEO 90100
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
|
Aerosol Foam Vehicle
Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
|
Calcipotriol BDP Gel
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
|
Gel Vehicle
Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
185
|
47
|
188
|
43
|
|
Overall Study
COMPLETED
|
175
|
38
|
174
|
29
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
14
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
LEO 90100
n=185 Participants
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
LEO 90100 aerosol foam
|
Aerosol Foam Vehicle
n=47 Participants
Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Aerosol foam vehicle
|
Calcipotriol BDP Gel
n=188 Participants
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Calcipotriol BDP gel
|
Gel Vehicle
n=43 Participants
Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Gel vehicle
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION 14.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
168 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
295 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gelTo compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
Outcome measures
| Measure |
LEO 90100
n=185 Participants
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
|
Calcipotriol BDP Gel
n=188 Participants
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
|
|---|---|---|
|
Treatment Success According to the PGA
|
38.3 percentage of subjects
|
22.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 4 for LEO 90100; Week 8 for calcipotriol BDP gelSubjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.
Outcome measures
| Measure |
LEO 90100
n=185 Participants
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
|
Calcipotriol BDP Gel
n=188 Participants
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
|
|---|---|---|
|
Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.
|
52.1 percentage of subjects
|
34.6 percentage of subjects
|
SECONDARY outcome
Timeframe: From Baseline to Week 12Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success. 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline.
Outcome measures
| Measure |
LEO 90100
n=185 Participants
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
|
Calcipotriol BDP Gel
n=188 Participants
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
|
|---|---|---|
|
Time to 'Treatment Success' According to PGA.
|
6 weeks
Interval 4.0 to
Upper quartile could not be estimated as less than 75% of subjects achieved treatment success.
|
NA weeks
Interval 6.0 to
Median could not be estimated for the calcipotriol BDP gel group as less than 50% of subjects achieved treatment success.
Upper quartile could not be estimated as less than 75% of subjects achieved treatment success.
|
SECONDARY outcome
Timeframe: Baseline to Week 4Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Outcome measures
| Measure |
LEO 90100
n=185 Participants
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
|
Calcipotriol BDP Gel
n=47 Participants
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
|
|---|---|---|
|
Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).
|
-30.5 units on a scale
Interval -33.4 to -27.5
|
-15.9 units on a scale
Interval -21.3 to -10.5
|
SECONDARY outcome
Timeframe: Baseline to Week 4; Baseline to Week 8Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).
Outcome measures
| Measure |
LEO 90100
n=185 Participants
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
|
Calcipotriol BDP Gel
n=188 Participants
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
|
|---|---|---|
|
Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).
|
-30.5 units on a scale
Interval -33.4 to -27.5
|
-28.5 units on a scale
Interval -31.4 to -25.6
|
Adverse Events
LEO 90100
Serious events: 4 serious events
Other events: 62 other events
Deaths: 0 deaths
Aerosol Foam Vehicle
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Calcipotriol BDP Gel
Serious events: 3 serious events
Other events: 60 other events
Deaths: 0 deaths
Gel Vehicle
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LEO 90100
n=185 participants at risk
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
LEO 90100 aerosol foam
|
Aerosol Foam Vehicle
n=47 participants at risk
Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Aerosol foam vehicle
|
Calcipotriol BDP Gel
n=188 participants at risk
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Calcipotriol BDP gel
|
Gel Vehicle
n=43 participants at risk
Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Gel vehicle
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.54%
1/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.54%
1/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Day 0 until week 12
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.53%
1/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.53%
1/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.54%
1/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.53%
1/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.54%
1/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
Other adverse events
| Measure |
LEO 90100
n=185 participants at risk
LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
LEO 90100 aerosol foam
|
Aerosol Foam Vehicle
n=47 participants at risk
Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Aerosol foam vehicle
|
Calcipotriol BDP Gel
n=188 participants at risk
Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
Calcipotriol BDP gel
|
Gel Vehicle
n=43 participants at risk
Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Gel vehicle
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.8%
7/185 • Number of events 7 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
2.1%
4/188 • Number of events 4 • Day 0 until week 12
|
4.7%
2/43 • Number of events 2 • Day 0 until week 12
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
5/185 • Number of events 6 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
4.8%
9/188 • Number of events 9 • Day 0 until week 12
|
4.7%
2/43 • Number of events 2 • Day 0 until week 12
|
|
Infections and infestations
Lower respiratory tract infection
|
2.2%
4/185 • Number of events 4 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.2%
6/185 • Number of events 6 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
2.7%
5/188 • Number of events 5 • Day 0 until week 12
|
4.7%
2/43 • Number of events 2 • Day 0 until week 12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
5/185 • Number of events 5 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
1.6%
3/188 • Number of events 3 • Day 0 until week 12
|
4.7%
2/43 • Number of events 2 • Day 0 until week 12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
5/185 • Number of events 6 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
1.1%
2/188 • Number of events 2 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.2%
4/185 • Number of events 4 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
3.7%
7/188 • Number of events 8 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
4/185 • Number of events 4 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
1.1%
2/188 • Number of events 2 • Day 0 until week 12
|
4.7%
2/43 • Number of events 2 • Day 0 until week 12
|
|
Vascular disorders
Hypertension
|
1.1%
2/185 • Number of events 2 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
3.7%
7/188 • Number of events 7 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
General disorders
Application site pruritus
|
0.54%
1/185 • Number of events 1 • Day 0 until week 12
|
4.3%
2/47 • Number of events 2 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Nervous system disorders
Headache
|
1.1%
2/185 • Number of events 2 • Day 0 until week 12
|
4.3%
2/47 • Number of events 2 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Infections and infestations
Sinusitis
|
1.1%
2/185 • Number of events 2 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
1.6%
3/188 • Number of events 3 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Infections and infestations
Gastroenteritis
|
0.54%
1/185 • Number of events 1 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Infections and infestations
Tooth abscess
|
0.54%
1/185 • Number of events 1 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Infections and infestations
Intertrigo candida
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Infections and infestations
Cellulitis
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Infections and infestations
Nail infection
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.54%
1/185 • Number of events 1 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.54%
1/185 • Number of events 1 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Skin and subcutaneous tissue disorders
Eythema
|
0.54%
1/185 • Number of events 1 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
2/185 • Number of events 2 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/185 • Number of events 2 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
1.1%
2/188 • Number of events 2 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
General disorders
Influenza like illness
|
1.6%
3/185 • Number of events 3 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
1.1%
2/188 • Number of events 2 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
General disorders
Application site pain
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
General disorders
Feeling cold
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Investigations
Vitamin D decreased
|
1.1%
2/185 • Number of events 2 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
1.6%
3/188 • Number of events 3 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Vascular disorders
Haematoma
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.53%
1/188 • Number of events 1 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/185 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
0.00%
0/43 • Day 0 until week 12
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/185 • Day 0 until week 12
|
0.00%
0/47 • Day 0 until week 12
|
0.00%
0/188 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.54%
1/185 • Number of events 1 • Day 0 until week 12
|
2.1%
1/47 • Number of events 1 • Day 0 until week 12
|
1.1%
2/188 • Number of events 2 • Day 0 until week 12
|
2.3%
1/43 • Number of events 1 • Day 0 until week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
- Publication restrictions are in place
Restriction type: OTHER