Trial Outcomes & Findings for Treatment for Endogenous Cushing's Syndrome (NCT NCT01838551)

Last Updated: 2021-04-19

Results Overview

The response to COR-003 is defined as mean UFC concentration ≤ULN following 6 months of maintenance phase therapy without a prior dose increase during that phase. The proportion of responders at the End of Maintenance Phase visit, following 6 months of treatment in the Maintenance Phase, for all dose groups combined was estimated using a generalized linear model with repeated measurements based on a binomial distribution with a logit link function and with region (US vs. non-US), concurrent CS medical conditions (diabetes \[Yes/No\], hypertension \[Yes/No\]), age (rounded median split based on the ITT population), sex, disease duration (years), prior CS medication (Yes/No), prior radiation therapy (Yes/No) as Baseline covariates and visit as an independent factor. The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

94 participants

Primary outcome timeframe

6 months of maintenance phase therapy without a prior dose increase during that phase

Results posted on

2021-04-19

Participant Flow

Following screening, subjects were considered enrolled in the study if they met eligibility criteria, which included confirmation of increased UFC levels as per the eligibility requirements and took at least 1 dose of levoketoconazole.

Participant milestones

Participant milestones
Measure	Levoketoconazole All Doses All doses used in the study combined
Overall Study STARTED	94
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Levoketoconazole All Doses All doses used in the study combined
Overall Study Adverse Event	16
Overall Study Death	1
Overall Study Lack of Efficacy	10
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	10
Overall Study No reason reported (2); surgery (2), cancer (1), sponsor request (1), bad clinical condition (1)	7

Baseline Characteristics

2 subjects did not have sufficient adequate baseline samples for mUFC determination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levoketoconazole All Doses n=94 Participants All doses used in the study combined
Age, Continuous	43.7 years STANDARD_DEVIATION 13.4 • n=94 Participants
Sex: Female, Male Female	77 Participants n=94 Participants
Sex: Female, Male Male	17 Participants n=94 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=94 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=94 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=94 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=94 Participants
Race (NIH/OMB) Asian	0 Participants n=94 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=94 Participants
Race (NIH/OMB) Black or African American	1 Participants n=94 Participants
Race (NIH/OMB) White	90 Participants n=94 Participants
Race (NIH/OMB) More than one race	0 Participants n=94 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=94 Participants
Region of Enrollment United States	28 participants n=94 Participants
Region of Enrollment Spain	3 participants n=94 Participants
Region of Enrollment Canada	1 participants n=94 Participants
Region of Enrollment Netherlands	5 participants n=94 Participants
Region of Enrollment Turkey	3 participants n=94 Participants
Region of Enrollment Belgium	3 participants n=94 Participants
Region of Enrollment Denmark	4 participants n=94 Participants
Region of Enrollment Poland	8 participants n=94 Participants
Region of Enrollment Italy	20 participants n=94 Participants
Region of Enrollment Israel	9 participants n=94 Participants
Region of Enrollment Bulgaria	6 participants n=94 Participants
Region of Enrollment France	2 participants n=94 Participants
Region of Enrollment Serbia	1 participants n=94 Participants
Region of Enrollment Germany	1 participants n=94 Participants
Baseline 24-hour mUFC	671 nmol/day STANDARD_DEVIATION 743 • n=92 Participants • 2 subjects did not have sufficient adequate baseline samples for mUFC determination

PRIMARY outcome

Timeframe: 6 months of maintenance phase therapy without a prior dose increase during that phase

Population: The primary efficacy analysis was based on the ITT population. Subjects were imputed as non-responders under any of the following conditions: withdrew anytime prior to the Month 6 of Maintenance phase; had a dose increase relative to the therapeutic dose during Maintenance phase; Month 6 mUFC data were missing or inadequate; or had received radiation therapy and exhibited no rebound increase in mUFC following withdrawal of levoketoconazole immediately after the end of Maintenance phase.

Outcome measures

Outcome measures
Measure	Levoketoconazole All Doses n=94 Participants All doses used in the study combined
Normalization in Urinary Free Cortisol in Patients With Endogenous Cushing's Syndrome.	.30 proportion of subjects meeting endpoint Interval 0.21 to 0.4

Adverse Events

Levoketoconazole All Doses

Serious events: 16 serious events

Other events: 92 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Levoketoconazole All Doses n=94 participants at risk All doses used in the study combined
Infections and infestations Pyelonephritis chronic	2.1% 2/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Infections and infestations Gastroenteritis	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Infections and infestations Urinary tract infection	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Electrocardiogram QT prolonged	2.1% 2/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Alanine aminotransferase increased	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Aspartate aminotransferase increased	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Gamma-glutamyltransferase increased	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Muscular weakness	2.1% 2/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Myalgia	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
General disorders Fatigue	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
General disorders Non-cardiac chest pain	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Metabolism and nutrition disorders Decreased appetite	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Metabolism and nutrition disorders Hypoglycemia	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumor	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Nervous system disorders Epilepsy	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Nervous system disorders Loss of consciousness	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Endocrine disorders Adrenal insufficiency	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Eye disorders Retinal artery occlusion	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Diarrhea	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Hemorrhoids	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Injury, poisoning and procedural complications Hyphaema	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Renal and urinary disorders Renal impairment	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Reproductive system and breast disorders Uterine polyp	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Vascular disorders Hypotension	1.1% 1/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.

Other adverse events

Other adverse events
Measure	Levoketoconazole All Doses n=94 participants at risk All doses used in the study combined
Cardiac disorders Palpitations	7.4% 7/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Abdominal pain	7.4% 7/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Abdominal pain upper	9.6% 9/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Diarrhea	14.9% 14/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Dyspepsia	5.3% 5/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.3% 5/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Nausea	33.0% 31/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Gastrointestinal disorders Vomiting	10.6% 10/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
General disorders Asthenia	6.4% 6/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
General disorders Edema peripheral	19.1% 18/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
General disorders Fatigue	17.0% 16/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Infections and infestations Nasopharyngitis	12.8% 12/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Infections and infestations Urinary tract infection	11.7% 11/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Alanine aminotransferase increased	16.0% 15/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Aspartate aminotransferase increased	12.8% 12/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Blood alkaline phosphatase increased	5.3% 5/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Electrocardiogram QT prolonged	9.6% 9/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Investigations Gamma-glutamyltransferase increased	11.7% 11/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Metabolism and nutrition disorders Decreased appetite	5.3% 5/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Metabolism and nutrition disorders Hypokalemia	13.8% 13/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Arthralgia	14.9% 14/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Back pain	7.4% 7/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.4% 6/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Myalgia	9.6% 9/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 6/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Nervous system disorders Dizziness	12.8% 12/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Nervous system disorders Dysgeusia	6.4% 6/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Nervous system disorders Headache	28.7% 27/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Psychiatric disorders Anxiety	7.4% 7/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Psychiatric disorders Insomnia	8.5% 8/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Reproductive system and breast disorders Menstruation irregular	5.3% 5/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.3% 5/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Skin and subcutaneous tissue disorders Alopecia	9.6% 9/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Skin and subcutaneous tissue disorders Dry skin	11.7% 11/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.4% 6/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Skin and subcutaneous tissue disorders Pruritus	6.4% 6/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Skin and subcutaneous tissue disorders Rash	8.5% 8/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.
Vascular disorders Hypertension	19.1% 18/94 • Reported adverse events are summarized for the period from the first day of study drug administration through the last day plus 30 days. For an individual subject, the maximum period of time for which adverse events were collected and summarized here (treatment-emergent only) was approximately 1 year, 11 months. For the ITT population, the median time period over which adverse events were collected and summarized was 1 year, 2 months; the mean time period was approximately 1 year. AEs were to be ascertained at each study visit by asking the subject how the subject had been since the last visit. A clinical observation, laboratory value, or imaging abnormality that the Investigator deemed clinically significant was to be recorded as an AE. An attempt was to be made to describe the AE in terms of a diagnosis. If a clear diagnosis could not be established, each sign and symptom was to be recorded individually.

Additional Information

Chief Medical Officer

Strongbridge Biopharma

Phone: 14845890392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All data generated from this study are the property of Cortendo Inc. (a subsidiary of Strongbridge Biopharma). Independent analyses and/or publication of data by Investigators is not permitted without prior written consent of Cortendo. Publication of results is to be conducted in accordance with Good Publication Practice as per Strongbridge publication policy.
Publication restrictions are in place

Restriction type: OTHER