Trial Outcomes & Findings for Study to Evaluate CORT125134 in Participants With Cushing's Syndrome (NCT NCT02804750)
NCT ID: NCT02804750
Last Updated: 2019-10-15
Results Overview
All treatment-emergent adverse events were recorded and summarized.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Group 1: up to Week 16; Group 2: up to Week 20
Results posted on
2019-10-15
Participant Flow
All enrolled participants who received at least 1 dose of study drug
Participant milestones
| Measure |
Group 1: Low-dose Group
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
|
Group 2: High-dose Group
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
|
|---|---|---|
|
Period 1
STARTED
|
17
|
18
|
|
Period 1
COMPLETED
|
17
|
15
|
|
Period 1
NOT COMPLETED
|
0
|
3
|
|
Period 2
STARTED
|
17
|
15
|
|
Period 2
COMPLETED
|
16
|
15
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
|
Period 3
STARTED
|
16
|
15
|
|
Period 3
COMPLETED
|
16
|
13
|
|
Period 3
NOT COMPLETED
|
0
|
2
|
|
Period 4
STARTED
|
0
|
12
|
|
Period 4
COMPLETED
|
0
|
7
|
|
Period 4
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Group 1: Low-dose Group
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
|
Group 2: High-dose Group
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
|
|---|---|---|
|
Period 1
Adverse Event
|
0
|
2
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
|
Period 2
Adverse Event
|
1
|
0
|
|
Period 3
Adverse Event
|
0
|
2
|
|
Period 4
Adverse Event
|
0
|
5
|
Baseline Characteristics
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome
Baseline characteristics by cohort
| Measure |
Group 1: Low-dose Group
n=17 Participants
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=18 Participants
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 13.62 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 13.46 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Hypertension
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Impaired Glucose Tolerance (IGT) / Type-2 Diabetes Mellitus (T2DM)
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Group 1: up to Week 16; Group 2: up to Week 20Population: All enrolled participants who received at least 1 dose of study drug
All treatment-emergent adverse events were recorded and summarized.
Outcome measures
| Measure |
Group 1: Low-dose Group
n=17 Participants
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=18 Participants
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With One or More Adverse Events
|
15 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Group 1: up to Week 16; Group 2: up to Week 20Population: All enrolled participants who received at least 1 dose of study drug
All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
Outcome measures
| Measure |
Group 1: Low-dose Group
n=17 Participants
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=18 Participants
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Group 1: Week 12 or last observation; Group 2: Week 16 or last observationPopulation: All enrolled participants with hypertension at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.
Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.
Outcome measures
| Measure |
Group 1: Low-dose Group
n=12 Participants
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=11 Participants
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134
|
41.67 Percentage of participants
Interval 15.17 to 72.33
|
63.64 Percentage of participants
Interval 30.79 to 89.07
|
SECONDARY outcome
Timeframe: Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)Population: All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.
Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication.
Outcome measures
| Measure |
Group 1: Low-dose Group
n=13 Participants
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=14 Participants
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134
|
23.08 Percentage of participants
Interval 5.04 to 53.81
|
0 Percentage of participants
Interval 0.0 to 23.16
|
POST_HOC outcome
Timeframe: Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)Population: All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had non-missing post-baseline data collected, with exclusions based on clinical judgment and/or important protocol deviations applied on a visit and outcome level rather than a participant level.
Improvement in glucose control was defined based on response criteria for Phase 3 study NCT03697109: a participant who experiences 1) a hemoglobin A1c (HbA1c) that is decreased by ≥ 0.5% from baseline, 2) a 2-hour oGTT plasma glucose that is normalized (\< 7.8 mmol/L) or decreased by ≥ 2.8 mmol/L from baseline, or 3) a total daily insulin dose that has decreased by ≥ 25% or total daily sulfonylurea dose that has decreased by ≥ 50% and an HbA1c that is unchanged or decreased from baseline.
Outcome measures
| Measure |
Group 1: Low-dose Group
n=13 Participants
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=12 Participants
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
|
|---|---|---|
|
Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109
|
15.38 Percentage of participants
Interval 1.92 to 45.45
|
50.00 Percentage of participants
Interval 21.09 to 78.91
|
Adverse Events
Group 1: Low-dose Group
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 2: High-dose Group
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Low-dose Group
n=17 participants at risk
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=18 participants at risk
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4.
|
|---|---|---|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
Group 1: Low-dose Group
n=17 participants at risk
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
|
Group 2: High-dose Group
n=18 participants at risk
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
4/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
16.7%
3/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
27.8%
5/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
22.2%
4/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
22.2%
4/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
16.7%
3/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Gingival hyperpigmentation
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
11.8%
2/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
11.8%
2/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Adverse drug reaction
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Fat tissue increased
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Flushing
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Influenza like illness
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Oedema peripheral
|
23.5%
4/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
27.8%
5/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Pain
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Peripheral swelling
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Chest pain
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Application site bruise
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Application site irritation
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Pyrexia
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.5%
4/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
38.9%
7/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
23.5%
4/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
22.2%
4/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
22.2%
4/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
22.2%
4/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
16.7%
3/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
27.8%
5/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Insomnia
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Migraine
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Vascular disorders
Hypertension
|
17.6%
3/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Vascular disorders
Contusion
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Dizziness
|
17.6%
3/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
22.2%
4/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Vascular disorders
Haematoma
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Vascular disorders
Phlebitis
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Fungal infection
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Lower respiratory tract infection
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Lymphangitis
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Candida infection
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.8%
2/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Application site vesicles
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
General disorders
Bronchitis
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Endocrine disorders
Hyperprolactinaemia
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Endocrine disorders
Diabetes mellitus inadequate control
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Investigations
C-reactive protein increased
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Investigations
Body temperature increased
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Investigations
Glucocorticoids abnormal
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Drug withdrawal syndrome
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Surgical and medical procedures
Medical device removal
|
5.9%
1/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
0.00%
0/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
16.7%
3/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Eye disorders
Astigmatism
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Eye disorders
Cataract
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Eye disorders
Photopsia
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
11.1%
2/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/17 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
5.6%
1/18 • Group 1: up to Week 16; Group 2: up to Week 20
All enrolled participants who received at least 1 dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Corcept Therapeutics as the Sponsor, has a proprietary interest in this study. Authorship and manuscript composition will reflect joint cooperation between multiple Investigators and sites and Corcept Therapeutics personnel. Authorship will be established before writing of the manuscript. Because this study involves multiple centers, no individual publications will be allowed before completion of the final report of the multicenter study except as agreed with Corcept Therapeutics.
- Publication restrictions are in place
Restriction type: OTHER