Trial Outcomes & Findings for A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) (NCT NCT05343455)
NCT ID: NCT05343455
Last Updated: 2024-12-03
Results Overview
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
330 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2024-12-03
Participant Flow
Participant milestones
| Measure |
DFD-29
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg
Doxycycline 40 mg modified release capsules
Doxycycline: Doxycycline 40 mg capsules
|
Placebo
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|---|
|
Overall Study
STARTED
|
123
|
125
|
82
|
|
Overall Study
COMPLETED
|
115
|
113
|
68
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
14
|
Reasons for withdrawal
| Measure |
DFD-29
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg
Doxycycline 40 mg modified release capsules
Doxycycline: Doxycycline 40 mg capsules
|
Placebo
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
7
|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
3
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
Baseline characteristics by cohort
| Measure |
DFD-29
n=123 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg
n=125 Participants
Doxycycline 40 mg modified release capsules
Doxycycline: Doxycycline 40 mg capsules
|
Placebo
n=82 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 14.05 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 13.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Total inflammatory lesion counts
|
24.1 Lesion count
STANDARD_DEVIATION 7.66 • n=5 Participants
|
25.0 Lesion count
STANDARD_DEVIATION 9.09 • n=7 Participants
|
24.2 Lesion count
STANDARD_DEVIATION 7.87 • n=5 Participants
|
24.5 Lesion count
STANDARD_DEVIATION 8.27 • n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
116 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
83 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Investigators Global Assessment (IGA) grade
Moderate
|
110 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
298 Participants
n=4 Participants
|
|
Investigators Global Assessment (IGA) grade
Severe
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) Score
0 = None
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) Score
1 = Mild
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) Score
2 = Moderate
|
41 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) Score
3 = Significant
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) Score
4 = Severe
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Intent-to-Treat Subjects
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Outcome measures
| Measure |
DFD-29
n=123 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=82 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
|
74 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16.Population: Intent-to-Treat Subjects
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
Outcome measures
| Measure |
DFD-29
n=123 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=82 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Change in Total Inflammatory Lesion Count Compared to Placebo.
|
-18.1 lesions
Standard Error 0.66
|
-11.2 lesions
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline to Week 16.Population: Intent-to-Treat Subjects
Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg. The IGA is a 5-point scale ranging from '0'-Clear to '4' Severe, in which lower scores indicate a better outcome.
Outcome measures
| Measure |
DFD-29
n=123 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=125 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
IGA Treatment Success Compared to Doxycycline.
|
74 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16.Population: Intent-to-Treat Subjects
Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Outcome measures
| Measure |
DFD-29
n=123 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=125 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Change in Total Inflammatory Lesion Count Compared to Doxycycline.
|
-18.1 lesions
Standard Error 0.71
|
-14.6 lesions
Standard Error 0.71
|
SECONDARY outcome
Timeframe: Baseline to Week 16.Population: Intent-to-Treat Subjects
Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo. The CEA is a 5-point scale ranging from '0' - No Redness to '4' - Fiery Redness, in which lower scores indicate a better outcome.
Outcome measures
| Measure |
DFD-29
n=123 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=82 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Clinician's Erythema Assessment (CEA) Change Compared to Placebo.
|
30 Participants
|
10 Participants
|
Adverse Events
DFD-29
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Doxycycline 40 mg
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DFD-29
n=122 participants at risk
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg
n=121 participants at risk
Doxycycline 40 mg modified release capsules
Doxycycline: Doxycycline 40 mg capsules
|
Placebo
n=82 participants at risk
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.82%
1/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.82%
1/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.2%
1/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
Other adverse events
| Measure |
DFD-29
n=122 participants at risk
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg
n=121 participants at risk
Doxycycline 40 mg modified release capsules
Doxycycline: Doxycycline 40 mg capsules
|
Placebo
n=82 participants at risk
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
5.7%
7/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
6.6%
8/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
6.1%
5/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
13/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
8.3%
10/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
15.9%
13/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Infections and infestations
Influenza
|
2.5%
3/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.83%
1/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.2%
1/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Infections and infestations
Gastroenteritis viral
|
2.5%
3/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.2%
1/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
2.5%
3/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
3.7%
3/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
3/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.2%
1/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Nervous system disorders
Headache
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
5.0%
6/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.2%
1/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
2.4%
2/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Eye disorders
Eczema eyelids
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.83%
1/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
General disorders
Fatigue
|
0.00%
0/122 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/82 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place