Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma (NCT NCT01472757)
NCT ID: NCT01472757
Last Updated: 2020-04-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
374 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2020-04-21
Participant Flow
374 subjects were randomised, and 373 received at least one dose of study drug; 1 subject was randomised but not treated.
Participant milestones
| Measure |
Placebo
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
93
|
95
|
94
|
|
Overall Study
Full Analysis Set
|
91
|
93
|
92
|
92
|
|
Overall Study
COMPLETED
|
61
|
80
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
30
|
13
|
19
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
0
|
|
Overall Study
Asthma exacerbation
|
4
|
1
|
2
|
1
|
|
Overall Study
Treatment period withdrawal criteria met
|
21
|
8
|
9
|
12
|
|
Overall Study
Protocol Violation
|
3
|
2
|
4
|
4
|
|
Overall Study
Other reasons
|
1
|
0
|
2
|
2
|
Baseline Characteristics
Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=91 Participants
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
n=93 Participants
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
n=95 Participants
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
n=94 Participants
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
Total
n=373 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
319 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
39.5 years
STANDARD_DEVIATION 15.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
19 participants
n=4 Participants
|
75 participants
n=21 Participants
|
|
Region of Enrollment
Philippines
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
24 participants
n=5 Participants
|
21 participants
n=4 Participants
|
91 participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
24 participants
n=4 Participants
|
90 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
24 participants
n=5 Participants
|
26 participants
n=4 Participants
|
98 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Full analysis set analyzed, but number of patients represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 2 subjects had no post-dose FEV1 assessments, baseline values were not carried forward
Outcome measures
| Measure |
Placebo
n=90 Participants
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
n=93 Participants
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
n=92 Participants
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
n=91 Participants
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)
|
0.19 Liters
Standard Deviation 0.36
|
0.32 Liters
Standard Deviation 0.46
|
0.38 Liters
Standard Deviation 0.30
|
0.38 Liters
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Number of participants analyzed aligns with Full Analysis Set.
Outcome measures
| Measure |
Placebo
n=91 Participants
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
n=93 Participants
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
n=92 Participants
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
n=92 Participants
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Number of Participants With Withdrawals Due to Worsening of Asthma
|
26 Participants
|
9 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Full Analysis Set analyzed, but number of patients analyzed represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 1 subject had no post-dose PEF assessment, baseline values were not carried forward
Outcome measures
| Measure |
Placebo
n=90 Participants
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
n=93 Participants
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
n=92 Participants
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
n=92 Participants
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
|
1.18 L/min
Standard Deviation 47.54
|
25.00 L/min
Standard Deviation 58.33
|
27.11 L/min
Standard Deviation 56.67
|
21.99 L/min
Standard Deviation 45.03
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Number of participants analyzed aligns with Full Analysis Set
Percentage of subjects that overall found it very easy, fairly easy or fairy difficult to use the inhaler, based on inhaler acceptability questionnaire.
Outcome measures
| Measure |
Placebo
n=91 Participants
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
n=93 Participants
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
n=92 Participants
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
n=92 Participants
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Assessment of Acceptability of the Device
Very Easy
|
57 Participants
|
66 Participants
|
58 Participants
|
59 Participants
|
|
Assessment of Acceptability of the Device
Fairly Easy
|
20 Participants
|
25 Participants
|
26 Participants
|
22 Participants
|
|
Assessment of Acceptability of the Device
Fairly Difficult
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Assessment of Acceptability of the Device
Missing
|
12 Participants
|
2 Participants
|
8 Participants
|
9 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
VR506 50 mcg
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
VR506 100 mcg
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
VR506 250 mcg
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=91 participants at risk
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
n=93 participants at risk
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
n=95 participants at risk
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
n=94 participants at risk
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
Other adverse events
| Measure |
Placebo
n=91 participants at risk
Placebo: Placebo delivered via a new dry powder inhaler
|
VR506 50 mcg
n=93 participants at risk
VR506 50 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 100 mcg
n=95 participants at risk
VR506 100 mcg inhalation powder delivered via a new dry powder inhaler
|
VR506 250 mcg
n=94 participants at risk
VR506 250 mcg inhalation powder delivered via a new dry powder inhaler
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
27.5%
25/91 • Number of events 28 • 12 weeks
|
17.2%
16/93 • Number of events 18 • 12 weeks
|
16.8%
16/95 • Number of events 17 • 12 weeks
|
12.8%
12/94 • Number of events 13 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.2%
2/91 • Number of events 2 • 12 weeks
|
3.2%
3/93 • Number of events 3 • 12 weeks
|
3.2%
3/95 • Number of events 3 • 12 weeks
|
3.2%
3/94 • Number of events 3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/91 • 12 weeks
|
2.2%
2/93 • Number of events 3 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL INFLAMMATION
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
2.1%
2/95 • Number of events 2 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC COUGH
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL SINUS HYPERSECRETION
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
2.2%
2/91 • Number of events 2 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM RETENTION
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.8%
8/91 • Number of events 8 • 12 weeks
|
2.2%
2/93 • Number of events 2 • 12 weeks
|
3.2%
3/95 • Number of events 4 • 12 weeks
|
2.1%
2/94 • Number of events 3 • 12 weeks
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
5.3%
5/95 • Number of events 6 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
2.1%
2/95 • Number of events 2 • 12 weeks
|
2.1%
2/94 • Number of events 2 • 12 weeks
|
|
Infections and infestations
PHARYNGITIS
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
2.2%
2/93 • Number of events 2 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
2.2%
2/91 • Number of events 2 • 12 weeks
|
3.2%
3/93 • Number of events 3 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/91 • 12 weeks
|
3.2%
3/93 • Number of events 3 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
2.1%
2/94 • Number of events 2 • 12 weeks
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
ACUTE SINUSITIS
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
CANDIDIASIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
TONSILLITIS
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
2.2%
2/91 • Number of events 2 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
FUNGAL INFECTION
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
INFLUENZA
|
2.2%
2/91 • Number of events 2 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Infections and infestations
TRACHEITIS
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Nervous system disorders
HEADACHE
|
4.4%
4/91 • Number of events 4 • 12 weeks
|
4.3%
4/93 • Number of events 5 • 12 weeks
|
3.2%
3/95 • Number of events 3 • 12 weeks
|
4.3%
4/94 • Number of events 4 • 12 weeks
|
|
Nervous system disorders
SINUS HEADACHE
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
GASTRODUODENITIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
HYPERCHLORHYDRIA
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Gastrointestinal disorders
GINGIVITIS
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEA
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
TORTICOLLIS
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.1%
1/91 • Number of events 4 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
General disorders
FATIGUE
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
General disorders
PYREXIA
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
General disorders
CHEST DISCOMFORT
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
General disorders
MALAISE
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
General disorders
PAIN
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
2.1%
2/94 • Number of events 2 • 12 weeks
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
1.1%
1/95 • Number of events 1 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Injury, poisoning and procedural complications
INJURY
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/91 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
1.1%
1/94 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/91 • 12 weeks
|
1.1%
1/93 • Number of events 1 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Eye disorders
LACRIMATION INCREASED
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Hepatobiliary disorders
CYTOLYTIC HEPATITIS
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
|
Hepatobiliary disorders
GALLBLADDER PAIN
|
1.1%
1/91 • Number of events 1 • 12 weeks
|
0.00%
0/93 • 12 weeks
|
0.00%
0/95 • 12 weeks
|
0.00%
0/94 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication can be delayed for 60 days for Sponsor review and revisions/deletions can be required. Furthermore, a 6-month delay to publication can be required by the Sponsor in order to take steps to protect its proprietary information and/or intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER