Trial Outcomes & Findings for A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT01424930)
NCT ID: NCT01424930
Last Updated: 2014-07-25
Results Overview
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1
Results posted on
2014-07-25
Participant Flow
The study was conducted from 29 September 2011 to 29 May 2013. Participants were recruited at 2 study centers in Canada.
Participant milestones
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
18
|
|
Overall Study
Completed Food Safety Evaluation
|
6
|
18
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
14
|
Reasons for withdrawal
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Progressive Disease
|
3
|
6
|
|
Overall Study
Screen Failure
|
0
|
1
|
|
Overall Study
Reason not specified
|
0
|
6
|
Baseline Characteristics
A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
n=7 Participants
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
n=18 Participants
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 7.26 • n=7 Participants
|
70.8 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1Population: Safety population: Participants who received at least 1 dose of study medication and contributed any safety data after the start of study treatment.
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Outcome measures
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
n=6 Participants
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
n=18 Participants
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7 and Day 14Population: Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.
The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Outcome measures
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
n=7 Participants
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
n=18 Participants
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Abiraterone
Day 7
|
218 ng/mL
Standard Deviation 168
|
196 ng/mL
Standard Deviation 234
|
|
Maximum Observed Plasma Concentration (Cmax) of Abiraterone
Day 14
|
265 ng/mL
Standard Deviation 229
|
342 ng/mL
Standard Deviation 289
|
SECONDARY outcome
Timeframe: Day 7 and Day 14Population: Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.
The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Outcome measures
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
n=7 Participants
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
n=18 Participants
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone
Day 7
|
2 hours
Full Range 1.0 - 8.1 • Interval 1.0 to 8.1
|
2 hours
Full Range 0.5 - 6.0 • Interval 0.5 to 6.0
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone
Day 14
|
2.5 hours
Full Range 1.0 - 3.0 • Interval 1.0 to 3.0
|
4.0 hours
Full Range 3.0 - 10.0 • Interval 3.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 7 and Day 14Population: Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.
The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Outcome measures
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
n=7 Participants
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
n=18 Participants
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
Day 7
|
1271 ng*h/mL
Standard Deviation 1279
|
973 ng*h/mL
Standard Deviation 667
|
|
Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)
Day 14
|
1264 ng*h/mL
Standard Deviation 963
|
1992 ng*h/mL
Standard Deviation 720
|
Adverse Events
Abiraterone+Prednisone (Low-fat Meal)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Abiraterone+Prednisone (High-fat Meal)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
n=7 participants at risk
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
n=18 participants at risk
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
14.3%
1/7
|
0.00%
0/18
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7
|
0.00%
0/18
|
|
General disorders
Fatigue
|
0.00%
0/7
|
5.6%
1/18
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
5.6%
1/18
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7
|
5.6%
1/18
|
|
Infections and infestations
Lobar Pneumonia
|
14.3%
1/7
|
0.00%
0/18
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
14.3%
1/7
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
14.3%
1/7
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.00%
0/7
|
5.6%
1/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.00%
0/7
|
5.6%
1/18
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/7
|
5.6%
1/18
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
|
5.6%
1/18
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/7
|
5.6%
1/18
|
|
Psychiatric disorders
Delirium
|
14.3%
1/7
|
5.6%
1/18
|
|
Vascular disorders
Hypotension
|
0.00%
0/7
|
5.6%
1/18
|
Other adverse events
| Measure |
Abiraterone+Prednisone (Low-fat Meal)
n=7 participants at risk
Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
|
Abiraterone+Prednisone (High-fat Meal)
n=18 participants at risk
Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
5.6%
1/18
|
|
Ear and labyrinth disorders
Ear Discomfort
|
14.3%
1/7
|
0.00%
0/18
|
|
Endocrine disorders
Cushingoid
|
14.3%
1/7
|
0.00%
0/18
|
|
Eye disorders
Blepharospasm
|
0.00%
0/7
|
5.6%
1/18
|
|
Eye disorders
Blindness Transient
|
0.00%
0/7
|
5.6%
1/18
|
|
Eye disorders
Eye Swelling
|
14.3%
1/7
|
5.6%
1/18
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/7
|
5.6%
1/18
|
|
Eye disorders
Vision Blurred
|
14.3%
1/7
|
0.00%
0/18
|
|
Eye disorders
Visual Impairment
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7
|
22.2%
4/18
|
|
Gastrointestinal disorders
Constipation
|
57.1%
4/7
|
38.9%
7/18
|
|
Gastrointestinal disorders
Diarrhoea
|
57.1%
4/7
|
33.3%
6/18
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
1/7
|
11.1%
2/18
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7
|
11.1%
2/18
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7
|
38.9%
7/18
|
|
Gastrointestinal disorders
Oral Discharge
|
14.3%
1/7
|
0.00%
0/18
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/7
|
5.6%
1/18
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7
|
11.1%
2/18
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7
|
22.2%
4/18
|
|
General disorders
Chills
|
14.3%
1/7
|
5.6%
1/18
|
|
General disorders
Facial Pain
|
14.3%
1/7
|
0.00%
0/18
|
|
General disorders
Fatigue
|
42.9%
3/7
|
61.1%
11/18
|
|
General disorders
Gait Disturbance
|
0.00%
0/7
|
5.6%
1/18
|
|
General disorders
Non-Cardiac Chest Pain
|
14.3%
1/7
|
16.7%
3/18
|
|
General disorders
Oedema Peripheral
|
57.1%
4/7
|
33.3%
6/18
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
11.1%
2/18
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
14.3%
1/7
|
5.6%
1/18
|
|
Immune system disorders
Hypersensitivity
|
14.3%
1/7
|
5.6%
1/18
|
|
Infections and infestations
Cystitis
|
0.00%
0/7
|
16.7%
3/18
|
|
Infections and infestations
Gastroenteritis Viral
|
14.3%
1/7
|
5.6%
1/18
|
|
Infections and infestations
Herpes Zoster
|
14.3%
1/7
|
5.6%
1/18
|
|
Infections and infestations
Influenza
|
0.00%
0/7
|
5.6%
1/18
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7
|
5.6%
1/18
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/7
|
5.6%
1/18
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7
|
0.00%
0/18
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7
|
16.7%
3/18
|
|
Injury, poisoning and procedural complications
Contusion
|
28.6%
2/7
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Excoriation
|
14.3%
1/7
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.00%
0/7
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/7
|
5.6%
1/18
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7
|
5.6%
1/18
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7
|
5.6%
1/18
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/7
|
5.6%
1/18
|
|
Investigations
Platelet Count Decreased
|
14.3%
1/7
|
0.00%
0/18
|
|
Investigations
Weight Decreased
|
14.3%
1/7
|
0.00%
0/18
|
|
Investigations
Weight Increased
|
14.3%
1/7
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
57.1%
4/7
|
44.4%
8/18
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/7
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.3%
1/7
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
71.4%
5/7
|
38.9%
7/18
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
28.6%
2/7
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
42.9%
3/7
|
44.4%
8/18
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
57.1%
4/7
|
38.9%
7/18
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
57.1%
4/7
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Exostosis of Jaw
|
0.00%
0/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/7
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
14.3%
1/7
|
22.2%
4/18
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
14.3%
1/7
|
11.1%
2/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
42.9%
3/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/7
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/7
|
22.2%
4/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
14.3%
1/7
|
0.00%
0/18
|
|
Nervous system disorders
Depressed Level of Consciousness
|
14.3%
1/7
|
5.6%
1/18
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/7
|
5.6%
1/18
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7
|
11.1%
2/18
|
|
Nervous system disorders
Headache
|
0.00%
0/7
|
27.8%
5/18
|
|
Nervous system disorders
Hypoaesthesia
|
14.3%
1/7
|
5.6%
1/18
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/7
|
5.6%
1/18
|
|
Nervous system disorders
Neuropathy Peripheral
|
14.3%
1/7
|
16.7%
3/18
|
|
Nervous system disorders
Paraesthesia
|
28.6%
2/7
|
11.1%
2/18
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/7
|
5.6%
1/18
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
14.3%
1/7
|
5.6%
1/18
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/7
|
5.6%
1/18
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7
|
11.1%
2/18
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
|
5.6%
1/18
|
|
Psychiatric disorders
"hallucination
|
0.00%
0/7
|
5.6%
1/18
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/7
|
5.6%
1/18
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7
|
5.6%
1/18
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/7
|
5.6%
1/18
|
|
Psychiatric disorders
Delirium
|
14.3%
1/7
|
5.6%
1/18
|
|
Psychiatric disorders
Depression
|
14.3%
1/7
|
5.6%
1/18
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7
|
11.1%
2/18
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/7
|
5.6%
1/18
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/7
|
5.6%
1/18
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7
|
11.1%
2/18
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7
|
0.00%
0/18
|
|
Renal and urinary disorders
Loss of Bladder Sensation
|
0.00%
0/7
|
5.6%
1/18
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7
|
5.6%
1/18
|
|
Renal and urinary disorders
Pollakiuria
|
14.3%
1/7
|
11.1%
2/18
|
|
Renal and urinary disorders
Urinary Hesitation
|
0.00%
0/7
|
5.6%
1/18
|
|
Renal and urinary disorders
Urinary Incontinence
|
28.6%
2/7
|
0.00%
0/18
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/7
|
11.1%
2/18
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/7
|
5.6%
1/18
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/7
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7
|
22.2%
4/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/7
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
14.3%
1/7
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/7
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
1/7
|
16.7%
3/18
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
14.3%
1/7
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/7
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7
|
11.1%
2/18
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/7
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
14.3%
1/7
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
14.3%
1/7
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/7
|
5.6%
1/18
|
|
Vascular disorders
Hot Flush
|
28.6%
2/7
|
27.8%
5/18
|
|
Vascular disorders
Hypertension
|
14.3%
1/7
|
11.1%
2/18
|
|
Vascular disorders
Hypotension
|
0.00%
0/7
|
11.1%
2/18
|
|
Vascular disorders
Peripheral Coldness
|
14.3%
1/7
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60