Trial Outcomes & Findings for Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients (NCT NCT02864498)
NCT ID: NCT02864498
Last Updated: 2022-10-10
Results Overview
Proportion of patients achieving an IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population at Week 8. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
321 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-10-10
Participant Flow
Approximately 300 patients (100 per treatment group) with moderate to severe Atopic Dermatitis (AD) were to be included in this study.
Eligible patients were randomized (1:1:1) to receive 1 g DS107, 2 g DS107, or placebo administered orally once daily for 8 weeks.
Participant milestones
| Measure |
1g DS107
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
112
|
104
|
|
Overall Study
COMPLETED
|
85
|
87
|
91
|
|
Overall Study
NOT COMPLETED
|
20
|
25
|
13
|
Reasons for withdrawal
| Measure |
1g DS107
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Unacceptable Adverse Events (AEs)
|
0
|
3
|
1
|
|
Overall Study
Patient Decision (Withdrawal of Consent to Participate)
|
6
|
10
|
4
|
|
Overall Study
Investigator Discretion
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
5
|
3
|
3
|
|
Overall Study
Other - Subject discontinued following database lock.
|
1
|
0
|
0
|
|
Overall Study
Other - Subject underwent knee surgery and stopped taking study medication.
|
0
|
1
|
0
|
|
Overall Study
Subject moved out of the country.
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients
Baseline characteristics by cohort
| Measure |
Treatment Group A
n=102 Participants
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
Treatment Group B
n=107 Participants
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Treatment Group C
n=102 Participants
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 15.40 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 16.42 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 16.28 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 16.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received.
Proportion of patients achieving an IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population at Week 8. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Outcome measures
| Measure |
1g DS107
n=102 Participants
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
n=107 Participants
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
n=102 Participants
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Proportion of Patients Achieving an Investigators Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population at Week 8.
|
0.35 Proportion of participants
|
0.29 Proportion of participants
|
0.33 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6 and Week 10Population: The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received.
Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Outcome measures
| Measure |
1g DS107
n=102 Participants
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
n=107 Participants
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
n=102 Participants
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10.
Week 4
|
0.07 Proportion of participants
|
0.03 Proportion of participants
|
0.06 Proportion of participants
|
|
Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10.
Week 2
|
0.02 Proportion of participants
|
0.00 Proportion of participants
|
0.01 Proportion of participants
|
|
Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10.
Week 6
|
0.15 Proportion of participants
|
0.19 Proportion of participants
|
0.16 Proportion of participants
|
|
Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10.
Week 10
|
0.32 Proportion of participants
|
0.31 Proportion of participants
|
0.43 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10Population: The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received.
Proportion of patients achieving a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, 8, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Outcome measures
| Measure |
1g DS107
n=102 Participants
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
n=107 Participants
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
n=102 Participants
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10
Week 8
|
0.38 Proportion of participants
|
0.31 Proportion of participants
|
0.34 Proportion of participants
|
|
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10
Week 2
|
0.03 Proportion of participants
|
0.02 Proportion of participants
|
0.03 Proportion of participants
|
|
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10
Week 4
|
0.08 Proportion of participants
|
0.07 Proportion of participants
|
0.08 Proportion of participants
|
|
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10
Week 6
|
0.18 Proportion of participants
|
0.21 Proportion of participants
|
0.20 Proportion of participants
|
|
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10
Week 10
|
0.34 Proportion of participants
|
0.31 Proportion of participants
|
0.41 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10Population: The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received.
Change from Baseline in EASI in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. It quantifies the severity of a patient's AD based on both lesion severity and the percent of Body Surface Area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The subscales used are summed in order to give a final EASI score. A decrease in EASI score represents a positive outcome for the patient.
Outcome measures
| Measure |
1g DS107
n=102 Participants
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
n=107 Participants
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
n=102 Participants
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 10
|
-12.15 EASI Index
Standard Deviation 9.205
|
-10.34 EASI Index
Standard Deviation 7.513
|
-11.56 EASI Index
Standard Deviation 8.918
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 2
|
-3.97 EASI Index
Standard Deviation 6.932
|
-2.94 EASI Index
Standard Deviation 6.120
|
-2.62 EASI Index
Standard Deviation 4.106
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 4
|
-7.64 EASI Index
Standard Deviation 7.366
|
-6.06 EASI Index
Standard Deviation 6.018
|
-6.86 EASI Index
Standard Deviation 6.656
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 6
|
-9.66 EASI Index
Standard Deviation 7.913
|
-8.64 EASI Index
Standard Deviation 6.863
|
-8.85 EASI Index
Standard Deviation 8.599
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 8
|
-11.73 EASI Index
Standard Deviation 8.894
|
-9.59 EASI Index
Standard Deviation 9.322
|
-11.03 EASI Index
Standard Deviation 8.852
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10Population: The Full Analysis Set (FAS) consists of all patients who were randomized to the study and received at least one dose of study drug. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the actual treatment received.
Change from Baseline in Numeric Rating Scale (NRS) for pruritus in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. Severity of pruritus related to AD will be self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale at screening and then daily starting at baseline through to the last study visit. A decrease in NRS represents a positive outcome for the patient.
Outcome measures
| Measure |
1g DS107
n=102 Participants
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
n=107 Participants
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
n=102 Participants
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 2
|
-1.0 score on a scale
Standard Deviation 1.74
|
-1.3 score on a scale
Standard Deviation 1.61
|
-1.3 score on a scale
Standard Deviation 1.98
|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 4
|
-1.8 score on a scale
Standard Deviation 1.97
|
-2.2 score on a scale
Standard Deviation 2.18
|
-2.2 score on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 6
|
-2.4 score on a scale
Standard Deviation 2.15
|
-2.7 score on a scale
Standard Deviation 2.38
|
-2.7 score on a scale
Standard Deviation 2.54
|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 8
|
-2.9 score on a scale
Standard Deviation 2.41
|
-3.2 score on a scale
Standard Deviation 2.53
|
-3.3 score on a scale
Standard Deviation 2.86
|
|
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Week 10
|
-3.5 score on a scale
Standard Deviation 2.56
|
-3.4 score on a scale
Standard Deviation 2.94
|
-3.6 score on a scale
Standard Deviation 2.84
|
Adverse Events
1g DS107
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
2g DS107
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1g DS107
n=105 participants at risk
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
n=112 participants at risk
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
n=104 participants at risk
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
Other adverse events
| Measure |
1g DS107
n=105 participants at risk
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
|
2g DS107
n=112 participants at risk
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
|
Placebo
n=104 participants at risk
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Ear and labyrinth disorders
Vertigo
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Eye disorders
Eye Pain
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
2.7%
3/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
6/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
5.4%
6/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.9%
2/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Flatulence
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.9%
2/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
5.4%
6/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
3.8%
4/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Toothache
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Gastrointestinal disorders
Vomiting
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
General disorders
Asthenia
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
General disorders
Chest Pain
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.9%
2/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
General disorders
Fatigue
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.9%
2/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
General disorders
Vessel Puncture Site Bruise
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Immune system disorders
Food Allegry
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Breast Abscess
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Eczema Infected
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Furuncle
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Infection
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.8%
2/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Influenza
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
2.7%
3/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Oral Candidiasis
|
1.9%
2/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Rhinitis
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Subcutaneous Abscess
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.8%
5/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.8%
2/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
3.8%
4/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Urinary Tract Infection
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.9%
2/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Viral Rash
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
2.7%
3/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Alanine Aminotransferase Abnormal
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Aspartate Aminotransferase Abnormal
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Bacterial Test Positive
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Blood Creatine Phosphokinase
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Blood Uric Acid Increased
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Crystal Urine
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Protein Urine
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Urinary Sediment Present
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
Urine Uric Acid
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.8%
2/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Nervous system disorders
Headache
|
2.9%
3/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
4.5%
5/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
6.7%
7/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Nervous system disorders
Migraine
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Psychiatric disorders
Depression
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Reproductive system and breast disorders
Breast Tenderness
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Respiratory, thoracic and mediastinal disorders
Dermatitis Allergic
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
4.5%
5/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
2/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
1.9%
2/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
2/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.89%
1/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Surgical and medical procedures
Breast Conserving Surgery
|
0.95%
1/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
|
Vascular disorders
Hypertension
|
0.00%
0/105 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.00%
0/112 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
0.96%
1/104 • 10 weeks.
Any undesirable experience occurring to a patient who has received at least one dose of study drug, whether or not considered related to the Investigational Medicinal Product(s) (IMP(s)).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place