Trial Outcomes & Findings for Open-label Treatment in Cushing's Syndrome (NCT NCT03621280)
NCT ID: NCT03621280
Last Updated: 2025-06-19
Results Overview
Proportions of participants with mUFC: 1) Less or equal to the ULN of the reference range, 2) Above the ULN to 1.5x the ULN, and 3) Above 1.5x the ULN.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
51 participants
Primary outcome timeframe
From parent study Baseline to final study visit or up to a maximum of 3 years, whichever comes first.
Results posted on
2025-06-19
Participant Flow
Prior to enrolling, participants were required to meet all eligibility criteria including specifications with respect to participation and/or completion of participation in COR-2012-01 and/or COR-2017-01.
There were 52 potential participants screened for participation in COR-2017-OLE; 51 were eligible for participation and 1 was not eligible for participation, as they failed to achieve a therapeutic dose in COR-2017-01.
Participant milestones
| Measure |
Levoketoconazole
Levoketoconazole taken twice daily up to 1200 mg daily
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
Baseline characteristics by cohort
| Measure |
All Participants
n=51 Participants
All participants who received at least 1 dose of levoketoconazole in COR-2017-OLE.
|
|---|---|
|
Age, Continuous
All Participants
|
44.1 years
STANDARD_DEVIATION 11.23 • n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Age, Continuous
Completers
|
48.3 years
STANDARD_DEVIATION 12.37 • n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Sex: Female, Male
All Participants · Female
|
40 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Sex: Female, Male
All Participants · Male
|
11 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Sex: Female, Male
Completers · Female
|
19 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Sex: Female, Male
Completers · Male
|
5 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
All Participants · American Indian or Alaska Native
|
1 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
All Participants · Asian
|
0 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
All Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
All Participants · Black or African American
|
3 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
All Participants · White
|
46 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
All Participants · More than one race
|
0 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
All Participants · Unknown or Not Reported
|
1 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
Completers · American Indian or Alaska Native
|
0 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
Completers · Asian
|
0 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
Completers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
Completers · Black or African American
|
1 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
Completers · White
|
23 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
Completers · More than one race
|
0 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Race (NIH/OMB)
Completers · Unknown or Not Reported
|
0 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Ethnicity (NIH/OMB)
All Participants · Hispanic or Latino
|
4 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Ethnicity (NIH/OMB)
All Participants · Not Hispanic or Latino
|
47 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Ethnicity (NIH/OMB)
All Participants · Unknown or Not Reported
|
0 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Ethnicity (NIH/OMB)
Completers · Hispanic or Latino
|
1 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Ethnicity (NIH/OMB)
Completers · Not Hispanic or Latino
|
23 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Ethnicity (NIH/OMB)
Completers · Unknown or Not Reported
|
0 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Region of Enrollment
United States
|
10 Participants
n=51 Participants
|
|
Region of Enrollment
Bulgaria
|
9 Participants
n=51 Participants
|
|
Region of Enrollment
Israel
|
6 Participants
n=51 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=51 Participants
|
|
Region of Enrollment
Greece
|
5 Participants
n=51 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=51 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=51 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=51 Participants
|
|
Region of Enrollment
Romania
|
3 Participants
n=51 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=51 Participants
|
|
Region of Enrollment
Hungary
|
2 Participants
n=51 Participants
|
|
Weight at COR-2017-OLE Baseline
All Participants
|
80.15 kg
STANDARD_DEVIATION 18.994 • n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Weight at COR-2017-OLE Baseline
Completers
|
76.58 kg
STANDARD_DEVIATION 17.127 • n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
BMI at COR-2017-OLE Baseline
All Participants
|
29.57 kg/m^2
STANDARD_DEVIATION 7.064 • n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
BMI at COR-2017-OLE Baseline
Completers
|
28.38 kg/m^2
STANDARD_DEVIATION 5.962 • n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Receiving Anti-diabetic Medication at COR-2017-OLE Baseline
All Participants
|
16 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Receiving Anti-diabetic Medication at COR-2017-OLE Baseline
Completers
|
8 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Receiving Anti-Hypertensive Medication at COR-2017-OLE Baseline
All Participants
|
33 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Receiving Anti-Hypertensive Medication at COR-2017-OLE Baseline
Completers
|
17 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Receiving Cholesterol-Reducing Medication at COR-2017-OLE Baseline
All Participants
|
8 Participants
n=51 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
|
Receiving Cholesterol-Reducing Medication at COR-2017-OLE Baseline
Completers
|
6 Participants
n=24 Participants • All Participants: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE Completers: Includes all participants that received at least 1 dose of levoketoconazole in COR-2017-OLE and met the criteria for study completion prior to 31 December 2022.
|
PRIMARY outcome
Timeframe: From parent study Baseline to final study visit or up to a maximum of 3 years, whichever comes first.Population: The number of participants at each timepoint is based on both the number of participants with evaluable mUFC data at each timepoint and the number of participants remaining in the study at each assessment timepoint.
Proportions of participants with mUFC: 1) Less or equal to the ULN of the reference range, 2) Above the ULN to 1.5x the ULN, and 3) Above 1.5x the ULN.
Outcome measures
| Measure |
All Participants
n=51 Participants
All participants who received at least 1 dose of levoketoconazole in COR-2017-OLE.
|
|---|---|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 6 · Less than or equal to ULN
|
20 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 6 · Above ULN to 1.5x ULN
|
10 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 6 · Above 1.5x ULN
|
10 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 12 · Less than or equal to ULN
|
15 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 12 · Above ULN to 1.5x ULN
|
11 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 12 · Above 1.5x ULN
|
11 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 18 · Less than or equal to ULN
|
16 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 18 · Above ULN to 1.5x ULN
|
6 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 18 · Above 1.5x ULN
|
6 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 24 · Less than or equal to ULN
|
18 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 24 · Above ULN to 1.5x ULN
|
5 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 24 · Above 1.5x ULN
|
6 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 30 · Less than or equal to ULN
|
15 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 30 · Above ULN to 1.5x ULN
|
3 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 30 · Above 1.5x ULN
|
6 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 36 · Less than or equal to ULN
|
7 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 36 · Above ULN to 1.5x ULN
|
3 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Month 36 · Above 1.5x ULN
|
3 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Original Baseline · Less than or equal to ULN
|
0 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Original Baseline · Above ULN to 1.5x ULN
|
1 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
Original Baseline · Above 1.5x ULN
|
50 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
COR-2017-OLE Baseline · Less than or equal to ULN
|
26 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
COR-2017-OLE Baseline · Above ULN to 1.5x ULN
|
12 Participants
|
|
Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)
COR-2017-OLE Baseline · Above 1.5x ULN
|
12 Participants
|
Adverse Events
All Participants
Serious events: 20 serious events
Other events: 48 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
All Participants
n=51 participants at risk
All participants who received at least 1 dose of levoketoconazole in COR-2017-OLE.
|
|---|---|
|
Infections and infestations
Corona virus infection
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Infections and infestations
Cellulitis
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Infections and infestations
Mediastinitis
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Infections and infestations
Septic shock
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Cardiac disorders
Angina unstable
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/51 • Number of events 2 • Up to 3 years; from start of treatment through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Endocrine disorders
Hyperadrenocorticism
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Hepatobiliary disorders
Hypertansaminasaemia
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Vascular disorders
Aortic dissection
|
2.0%
1/51 • Number of events 2 • Up to 3 years; from start of treatment through end of study.
|
|
Vascular disorders
Essential hypertension
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Ear and labyrinth disorders
Ear canal stenosis
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Nervous system disorders
Presyncope
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Psychiatric disorders
Major depression
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
|
Surgical and medical procedures
Pituitary tumour removal
|
2.0%
1/51 • Number of events 1 • Up to 3 years; from start of treatment through end of study.
|
Other adverse events
| Measure |
All Participants
n=51 participants at risk
All participants who received at least 1 dose of levoketoconazole in COR-2017-OLE.
|
|---|---|
|
Infections and infestations
Corona virus infection
|
15.7%
8/51 • Number of events 8 • Up to 3 years; from start of treatment through end of study.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
5/51 • Number of events 8 • Up to 3 years; from start of treatment through end of study.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Cardiac disorders
Palpitations
|
5.9%
3/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Ear and labyrinth disorders
Vertigo
|
9.8%
5/51 • Number of events 5 • Up to 3 years; from start of treatment through end of study.
|
|
Endocrine disorders
Adrenal insufficiency
|
9.8%
5/51 • Number of events 7 • Up to 3 years; from start of treatment through end of study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
17/51 • Number of events 26 • Up to 3 years; from start of treatment through end of study.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
7/51 • Number of events 11 • Up to 3 years; from start of treatment through end of study.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
3/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • Number of events 6 • Up to 3 years; from start of treatment through end of study.
|
|
General disorders
Fatigue
|
19.6%
10/51 • Number of events 13 • Up to 3 years; from start of treatment through end of study.
|
|
General disorders
Oedema peripheral
|
7.8%
4/51 • Number of events 5 • Up to 3 years; from start of treatment through end of study.
|
|
General disorders
Pyrexia
|
7.8%
4/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.8%
5/51 • Number of events 5 • Up to 3 years; from start of treatment through end of study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.8%
4/51 • Number of events 5 • Up to 3 years; from start of treatment through end of study.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
3/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.5%
12/51 • Number of events 15 • Up to 3 years; from start of treatment through end of study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
3/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.7%
7/51 • Number of events 8 • Up to 3 years; from start of treatment through end of study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
5/51 • Number of events 7 • Up to 3 years; from start of treatment through end of study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Nervous system disorders
Headache
|
23.5%
12/51 • Number of events 21 • Up to 3 years; from start of treatment through end of study.
|
|
Nervous system disorders
Dizziness
|
9.8%
5/51 • Number of events 5 • Up to 3 years; from start of treatment through end of study.
|
|
Nervous system disorders
Sciatica
|
5.9%
3/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Psychiatric disorders
Depression
|
9.8%
5/51 • Number of events 5 • Up to 3 years; from start of treatment through end of study.
|
|
Psychiatric disorders
Insomnia
|
7.8%
4/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
4/51 • Number of events 5 • Up to 3 years; from start of treatment through end of study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.8%
6/51 • Number of events 8 • Up to 3 years; from start of treatment through end of study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
5/51 • Number of events 6 • Up to 3 years; from start of treatment through end of study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
3/51 • Number of events 3 • Up to 3 years; from start of treatment through end of study.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.9%
3/51 • Number of events 4 • Up to 3 years; from start of treatment through end of study.
|
|
Vascular disorders
Hypertension
|
27.5%
14/51 • Number of events 20 • Up to 3 years; from start of treatment through end of study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restrictions aligned with local requirements, allow Sponsor time to submit a multi-center publication after study completion prior to individual site publication. The Sponsor could review results communications before release, request changes and/or removal of confidential information and prohibit communication about trial results for more than 60 days but less than or equal to 6 months from the time submitted for Sponsor review. The Sponsor cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER