Trial Outcomes & Findings for Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion (NCT NCT00422201)

Last Updated: 2019-10-11

Results Overview

Criteria for improvement or normalization of glycemic disorders: A. For diabetic patients (known or diagnosed at pre-inclusion visit) * Decrease in HbA1c \> 0.3% B. For patients with IGT * Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT \< 7.8 mmol/L (140 mg/dL) D. For patients with IFG If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion: \- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT \< 7.8 mmol/L (140 mg/dL) If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0): \- Normalization of fasting plasma glucose (fasting plasma glucose \< 5.5 mmol/L (100 mg/dL)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

8 weeks at steady dose

Results posted on

2019-10-11

Participant Flow

18 patients recruited. Recruitment terminated.

Participant milestones

Participant milestones
Measure	Single Arm Mifepristone Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion. This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.
Overall Study STARTED	18
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone n=18 Participants Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion. This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	53.9 years STANDARD_DEVIATION 12.48 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment France	2 participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Region of Enrollment Netherlands	6 participants n=5 Participants
Region of Enrollment Germany	1 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks at steady dose

Population: 18 patients were recruited. 7 completed the study but only 3 according to the last protocol version (in which primary efficacy criteria were changed), so only these 3 patients were to be analysed

Outcome measures

Outcome measures
Measure	Mifepristone n=3 Participants Single arm. Study medication was administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion. This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.
Glycemic Disorders Improved or Normalized	2 participants

SECONDARY outcome

Timeframe: 8 weeks at steady dose

Population: 18 patients were recruited. 7 completed the study but only 3 according to the last protocol version, so only these 3 patients were to be analysed

Criteria for secondary glycemic disorder improvement of clinical symptoms attributable to the Cushing's syndrome A. For diabetic patients * Improvement of the following parameters: glycemic profile, fasting blood glucose, fructosamine, 2-hour OGTT (for diabetics diagnosed at screening) * Number of anti-diabetics treatment or dose of anti-diabetics treatment for diabetic patients already on diabetes treatment at inclusion * Doses of insulin for insulin-treated patients B. For patients with IGT * HbA1c * Fructosamine C. For patients with IFG * HbA1c * Fructosamine D. For all patients * Fasting plasma insulin * Area Under the Curve of OGTT results when OGTT performed * HOMA index

Outcome measures

Outcome measures
Measure	Mifepristone n=3 Participants Single arm. Study medication was administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion. This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.
Features of Cushing's Syndrome	2 participants

Adverse Events

Mifepristone

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mifepristone n=17 participants at risk Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion. This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.
Renal and urinary disorders Renal acute failure	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hyperkalaemia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Abscess limb	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Pneumocystis jiroveci	11.8% 2/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Endocrine disorders Adrenal insufficiency	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hypokalaemia	11.8% 2/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
General disorders Oedema	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
General disorders Fatigue	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Vascular disorders Hypotension	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Renal and urinary disorders Renal impairment	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Cardiac disorders Myocardial infarction	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Reproductive system and breast disorders Uterine polyp	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.

Other adverse events

Other adverse events
Measure	Mifepristone n=17 participants at risk Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion. This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study.
Gastrointestinal disorders Nausea	41.2% 7/17 • Number of events 30 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hypokalaemia	52.9% 9/17 • Number of events 29 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Decreased apetite	23.5% 4/17 • Number of events 8 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hyperkalaemia	5.9% 1/17 • Number of events 3 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Dehydratation	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hypernatremia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hypocalcaemia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hypomagnesaemia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Metabolism and nutrition disorders Hyponatraemia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Gastrointestinal disorders vomiting	23.5% 4/17 • Number of events 11 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Gastrointestinal disorders Dry mouth	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Labyrinthitis	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Nasopharyngitis	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Parotitis	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Pneumonia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Sputum purulent	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Infections and infestations Upper respiratory tract infection	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Endocrine disorders Adrenal insuffisiency	35.3% 6/17 • Number of events 14 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Endocrine disorders Steroid withdrawal syndrome	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Endocrine disorders Hypothyroidism	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
General disorders Fatigue	41.2% 7/17 • Number of events 21 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
General disorders Pyrexia	17.6% 3/17 • Number of events 5 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
General disorders Oedema peripheral	11.8% 2/17 • Number of events 4 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
General disorders Oedema	11.8% 2/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
General disorders pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations C-reactive protein increased	17.6% 3/17 • Number of events 3 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Blood creatinine increased	11.8% 2/17 • Number of events 3 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Protein total decrased	11.8% 2/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Blood albumin decreased	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Blood corticotrophin increased	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Blood cortisol increased	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Blood urea increased	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations High density lipoprotein decreased	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Alanine aminotransferase increased	5.9% 1/17 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Blood pressure decreased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Blood thyroid stimulating hormone increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Cortisol free urine	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Hepatic enzyme increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Laboratory test abnormal	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Low density lipoprotein increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Osteocalcin increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Proteinuria	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Transaminases increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations urine potassium increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations urine sodium increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Investigations Weight increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Renal and urinary disorders Microalbuminuria	5.9% 1/17 • Number of events 3 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Renal and urinary disorders Nocturia	5.9% 1/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Renal and urinary disorders Renal failure acute	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Renal and urinary disorders Haematuria	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Renal and urinary disorders Micturition frequency increased	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Renal and urinary disorders Pollakiuria	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Musculoskeletal and connective tissue disorders Back pain	11.8% 2/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Musculoskeletal and connective tissue disorders Muscular weakness	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Musculoskeletal and connective tissue disorders osteoarthritis	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Musculoskeletal and connective tissue disorders Pain in jaw	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Headache	29.4% 5/17 • Number of events 25 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Tremor	11.8% 2/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Ageusia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Burning sensation	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Hypersomnia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Memory impairment	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Nervous system disorders Somnolence	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Vascular disorders Hypotension	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Vascular disorders Orthostatic hypotension	11.8% 2/17 • Number of events 2 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Vascular disorders Hypertension	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Skin and subcutaneous tissue disorders Pigmentation disorder	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Blood and lymphatic system disorders Anaemia	17.6% 3/17 • Number of events 4 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Respiratory, thoracic and mediastinal disorders Chest pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Cardiac disorders Palpitations	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Reproductive system and breast disorders Endometrial hyperplasia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Reproductive system and breast disorders Endometrial hypertrophy	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Eye disorders Diplopia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.
Reproductive system and breast disorders Gynaecomastia	5.9% 1/17 • Number of events 1 • Adverse events were collected from enrollment to the end of the study ie up to 12 months. Number of patients at risk corresponds to the number of patients who have received study treatment. Among the 18 patients enrolled, 17 received study treament and are considered in the set of population at risk.

Additional Information

Head of Clinical Research

HRA Pharma

Phone: 0033140331130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60