Study to Evaluate CORT125134 in Participants With Cushing... | NCT02804750

Description Module

Label	Type	Description	Intervention Names
Group 1: Low-dose Group	Experimental	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4.	Drug: CORT125134
Group 2: High-dose Group	Experimental	250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.	Drug: CORT125134

Name	Type	Description	Arm Group Labels	Other Names
CORT125134	Drug		Group 1: Low-dose Group Group 2: High-dose Group

Measure	Description	Time Frame
Percentage of Participants With One or More Adverse Events	All treatment-emergent adverse events were recorded and summarized.	Group 1: up to Week 16; Group 2: up to Week 20
Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events	All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.	Group 1: up to Week 16; Group 2: up to Week 20

Measure	Description	Time Frame
Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134	Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.

Name	Affiliation	Role
Andreas G Moraitis, MD	Corcept Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Laguna Hills	California	92653	United States

PubMed Identifier	Type	Citation	Retractions
35058882	Derived	Pivonello R, Munster PN, Terzolo M, Ferrigno R, Simeoli C, Puglisi S, Bali U, Moraitis AG. Glucocorticoid Receptor Antagonism Upregulates Somatostatin Receptor Subtype 2 Expression in ACTH-Producing Neuroendocrine Tumors: New Insight Based on the Selective Glucocorticoid Receptor Modulator Relacorilant. Front Endocrinol (Lausanne). 2022 Jan 4;12:793262. doi: 10.3389/fendo.2021.793262. eCollection 2021.
34335465

ID	Title	Description
FG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 15, 2018	Aug 16, 2019

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00047.6± 13.62 BG00149.5± 13.46 BG00248.6± 13.37

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0009 BG00116 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Netherlands

Title	Measurements
	BG0002 BG0010 BG002

Hypertension

Confirmed with a mean systolic blood pressure (BP) of 130-170 mmHg and/or a mean diastolic BP of 85-110 mmHg based on the 24-hour ambulatory BP measurement.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00012 BG00111

Impaired Glucose Tolerance (IGT) / Type-2 Diabetes Mellitus (T2DM)

Either a fasting glucose > 126 mg/dL and a 2-hour Oral Glucose Tolerance Test (oGTT) result for plasma glucose ≥ 200 mg/dL at 2 hours (for T2DM), or a 2-hour oGTT result for plasma glucose in the range of ≥ 140 mg/dL to < 200 mg/dL (for IGT).

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00013 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With One or More Adverse Events

All treatment-emergent adverse events were recorded and summarized.

All enrolled participants who received at least 1 dose of study drug

Posted

Count of Participants

Participants

Group 1: up to Week 16; Group 2: up to Week 20

ID	Title	Description
OG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
OG001	Group 2: High-dose Group	250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.

Units	Counts
Participants	OG00017 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00015 OG00118

Primary

Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events

All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.

All enrolled participants who received at least 1 dose of study drug

Posted

Count of Participants

Participants

Group 1: up to Week 16; Group 2: up to Week 20

ID	Title	Description
OG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
OG001	Group 2: High-dose Group	250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134

Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.

All enrolled participants with hypertension at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

Group 1: Week 12 or last observation; Group 2: Week 16 or last observation

ID	Title	Description
OG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
OG001	Group 2: High-dose Group	250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.

Units

Secondary

Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134

Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication.

All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)

ID	Title	Description
OG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
OG001	Group 2: High-dose Group	250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.

Post-Hoc

Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109

Improvement in glucose control was defined based on response criteria for Phase 3 study NCT03697109: a participant who experiences 1) a hemoglobin A1c (HbA1c) that is decreased by ≥ 0.5% from baseline, 2) a 2-hour oGTT plasma glucose that is normalized (< 7.8 mmol/L) or decreased by ≥ 2.8 mmol/L from baseline, or 3) a total daily insulin dose that has decreased by ≥ 25% or total daily sulfonylurea dose that has decreased by ≥ 50% and an HbA1c that is unchanged or decreased from baseline.

All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had non-missing post-baseline data collected, with exclusions based on clinical judgment and/or important protocol deviations applied on a visit and outcome level rather than a participant level.

Posted

Number

95% Confidence Interval

Percentage of participants

Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)

ID	Title	Description
OG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
OG001	Group 2: High-dose Group

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected17 at risk EG0013 affected18 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected17 at risk EG0015 affected18 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected17 at risk EG0011 affected18 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0012 affected18 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0011 affected18 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0014 affected18 at risk
Flatulence	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0012 affected18 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0014 affected18 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0013 affected18 at risk
Gingival hyperpigmentation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected17 at risk EG0011 affected18 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected17 at risk EG0012 affected18 at risk
Adverse drug reaction	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Fat tissue increased	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Flushing	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0011 affected18 at risk
Influenza like illness	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected17 at risk EG0015 affected18 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0011 affected18 at risk
Peripheral swelling	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0012 affected18 at risk
Chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0012 affected18 at risk
Application site bruise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Application site irritation	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected17 at risk EG0017 affected18 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected17 at risk EG0014 affected18 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected17 at risk EG0014 affected18 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0011 affected18 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0014 affected18 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0013 affected18 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Medial tibial stress syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected17 at risk EG0015 affected18 at risk
Somnolence	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0012 affected18 at risk
Sciatica	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0012 affected18 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Insomnia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Migraine	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Nerve root compression	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Nystagmus	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0011 affected18 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0011 affected18 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Hypothyroidism	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected17 at risk EG0010 affected18 at risk
Contusion	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Dizziness	General disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected17 at risk EG0014 affected18 at risk
Haematoma	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Peripheral venous disease	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Phlebitis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Fungal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Lymphangitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0011 affected18 at risk
Candida infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Enterobacter infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Herpes zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected17 at risk EG0011 affected18 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Application site vesicles	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Folliculitis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Bronchitis	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0012 affected18 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Hyperprolactinaemia	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Diabetes mellitus inadequate control	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
C-reactive protein increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0012 affected18 at risk
Body temperature increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Glucocorticoids abnormal	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Drug withdrawal syndrome	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Emotional distress	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Sleep disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Medical device removal	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected17 at risk EG0010 affected18 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0013 affected18 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0012 affected18 at risk
Deafness	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Astigmatism	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Cataract	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Photopsia	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0012 affected18 at risk
Polyuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Pilonidal cyst	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk

ID	Term
D003480	Cushing Syndrome
D047748	Pituitary ACTH Hypersecretion
D000182	ACTH Syndrome, Ectopic
D003924	Diabetes Mellitus, Type 2
D006973	Hypertension
D018268	Adrenocortical Carcinoma
D000306	Adrenal Cortex Neoplasms

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009384	Paraneoplastic Endocrine Syndromes
D010257	Paraneoplastic Syndromes
D009369	Neoplasms
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D000310	Adrenal Gland Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D000303	Adrenal Cortex Diseases

ID	Title	Description
BG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.
BG001	Group 2: High-dose Group	250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. Period 4 was followed by a 4-week follow-up period.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1: Low-dose Group	100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period.	0	17	0	17	15	17
EG001	Group 2: High-dose Group	250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4.	0	18	4	18	18	18

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pilonidal cyst	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk
Polyneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected17 at risk EG0011 affected18 at risk