Trial Outcomes & Findings for Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer (NCT NCT03646162)
NCT ID: NCT03646162
Last Updated: 2021-12-03
Results Overview
Percentage of change in frequency of moderate to severe hot flashes at 6 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
Veru-944 10 mg
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
26
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
Veru-944 10 mg
n=30 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=30 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=31 Participants
Placebo daily
Placebo: Placebo
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 5.79 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 8.84 • n=7 Participants
|
69.1 years
STANDARD_DEVIATION 8.05 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 7.50 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
91 participants
n=4 Participants
|
|
Moderate to Severe Hot Flashes
|
41.5 Percentage hot flashes moderate severe
STANDARD_DEVIATION 36.52 • n=5 Participants
|
29.7 Percentage hot flashes moderate severe
STANDARD_DEVIATION 22.2 • n=7 Participants
|
33.7 Percentage hot flashes moderate severe
STANDARD_DEVIATION 20.23 • n=5 Participants
|
34.9 Percentage hot flashes moderate severe
STANDARD_DEVIATION 26.25 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Percentage of change in frequency of moderate to severe hot flashes at week 6
Percentage of change in frequency of moderate to severe hot flashes at 6 weeks
Outcome measures
| Measure |
Veru-944 10 mg
n=26 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=27 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=30 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks
|
-19.72 Percentage of change in frequency
Standard Deviation 8.840
|
-42.24 Percentage of change in frequency
Standard Deviation 8.196
|
-46.59 Percentage of change in frequency
Standard Deviation 7.760
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Percentage change in severity of moderate to severe hot flashes compared to baseline at 6 weeks
Change in severity of moderate to severe hot flashes compared to baseline at 6 weeks
Outcome measures
| Measure |
Veru-944 10 mg
n=23 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=25 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=27 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Percentage Change in Severity of Moderate to Severe Hot Flashes at 6 Weeks
|
-0.21 percentage of change
Standard Deviation 0.386
|
-0.31 percentage of change
Standard Deviation 0.416
|
-0.35 percentage of change
Standard Deviation 0.508
|
SECONDARY outcome
Timeframe: Weeks 12Population: Percentage of change from Baseline to Week 12
Mean change in frequency of moderate to severe hot flashes compared to baseline at weeks 12
Outcome measures
| Measure |
Veru-944 10 mg
n=26 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=27 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=30 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Change of Frequency of Moderate to Severe Hot Flashes at Week 12
|
-39.94 percentage of change
Standard Error 8.458
|
-51.95 percentage of change
Standard Error 8.574
|
-52.70 percentage of change
Standard Error 7.881
|
SECONDARY outcome
Timeframe: Week 12Population: Mean percentage change from baseline to week 12
Mean change in severity of moderate to severe hot flashes compared to baseline at week 12
Outcome measures
| Measure |
Veru-944 10 mg
n=26 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=27 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=30 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Change in Severity of Moderate to Severe Hot Flashes at Week 12
|
-12.05 percentage of change
Standard Error 5.014
|
-16.93 percentage of change
Standard Error 5.061
|
-22.48 percentage of change
Standard Error 4.674
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Change in C-telopeptide concentration at day 84 compared to baseline
Change in C-telopeptide concentration at day 84 compared to baseline
Outcome measures
| Measure |
Veru-944 10 mg
n=27 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=30 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=31 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Change in Bone Turnover Markers C-telopeptide (CTX)
|
419.7 ng/L
Standard Deviation 262
|
362.1 ng/L
Standard Deviation 305.44
|
466 ng/L
Standard Deviation 347.3
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Change in bone specific alkaline phosphatase at day 84 compared to baseline
Change in bone specific alkaline phosphatase at day 84 compared to baseline
Outcome measures
| Measure |
Veru-944 10 mg
n=28 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=30 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=31 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Change in Bone Turnover Markers Alkaline Phosphatase
|
13.89 ug/L
Standard Deviation 4.598
|
15.72 ug/L
Standard Deviation 22.468
|
13.12 ug/L
Standard Deviation 6.074
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 84 DaysChange in serum PSA concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 84 DaysChange in serum total testosterone concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 84 daysPopulation: Change in serum free testosterone concentration comparing baseline to day 84
Change in serum free testosterone concentration comparing baseline to day 84
Outcome measures
| Measure |
Veru-944 10 mg
n=29 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=30 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=29 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Change in Serum Free Testosterone
|
1.16 ng/L
Standard Deviation 0.895
|
1.38 ng/L
Standard Deviation 4.873
|
1.0 ng/L
Standard Deviation 1.635
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 84 daysPopulation: Change in serum SHBG concentration comparing baseline to day 84
Change in serum SHBG concentration comparing baseline to day 30, baseline to day 60 and baseline to day 84 for each treatment group
Outcome measures
| Measure |
Veru-944 10 mg
n=29 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=30 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=30 Participants
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Change in Serum SHBG
|
55.7 nmol/L
Standard Deviation 28.27
|
113.5 nmol/L
Standard Deviation 60.53
|
54.1 nmol/L
Standard Deviation 24.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 114 daysIncidence of Treatment-Emergent Adverse Events will be tabulated by MedDRA terms and system organ class. The incidence of AEs and the maximum intensity and frequency of AEs will be summarized. The intensity of AE will be graded according to CTCAE version 4. Changes from baseline will be computed and tested for significant change from baseline to day 114
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: Day 84Population: Subjects with a BMI \>25 kg/m2 who had trough plasma concentrations ≥195 ng/mL vs \<195 ng/mL Change in moderate and severe hot flash frequency at Week 12
Post-hoc exploratory MMRM analysis was conducted to explore the effect of trough plasma concentration at Week12 on the change in frequency of moderate and severe hot flashes from Baseline to Week 12 in subjects with a BMI \>25 kg/m2.
Outcome measures
| Measure |
Veru-944 10 mg
n=9 Participants
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=56 Participants
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Post-hoc Analysis on the Percentage Change in Frequency of Moderate and Severe Hot Flashes From Baseline to Week 12; Exposure Response Assessment
|
-77.60 percentage of change
Standard Deviation 14.542
|
-50.14 percentage of change
Standard Deviation 5.842
|
—
|
Adverse Events
Veru-944 10 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Veru-944 50 mg
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Veru-944 10 mg
n=30 participants at risk
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=30 participants at risk
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=31 participants at risk
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • 15 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • 15 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • 15 months
|
0.00%
0/31 • 15 months
|
Other adverse events
| Measure |
Veru-944 10 mg
n=30 participants at risk
Veru-944 10 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Veru-944 50 mg
n=30 participants at risk
Veru-944 50 mg daily
Veru-944: Treat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
|
Placebo
n=31 participants at risk
Placebo daily
Placebo: Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • Number of events 1 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Gastrointestinal disorders
Nauseas
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/30 • 15 months
|
0.00%
0/31 • 15 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/30 • 15 months
|
10.0%
3/30 • Number of events 3 • 15 months
|
0.00%
0/31 • 15 months
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • Number of events 2 • 15 months
|
0.00%
0/30 • 15 months
|
0.00%
0/31 • 15 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Infections and infestations
Influenza
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
General disorders
Fatigue
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
9.7%
3/31 • Number of events 3 • 15 months
|
|
General disorders
Oedema Peripheral
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/30 • 15 months
|
0.00%
0/31 • 15 months
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/30 • 15 months
|
0.00%
0/31 • 15 months
|
|
General disorders
Peripheral Swelling
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Renal and urinary disorders
Post micturition dribble
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Renal and urinary disorders
Renal Mass
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
Atrial Fibrillation
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Eye disorders
Vision Blurred
|
3.3%
1/30 • Number of events 1 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Investigations
Cardiac Murmur
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/30 • 15 months
|
0.00%
0/31 • 15 months
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
6.5%
2/31 • Number of events 2 • 15 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • 15 months
|
3.3%
1/30 • Number of events 1 • 15 months
|
0.00%
0/31 • 15 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/30 • 15 months
|
0.00%
0/30 • 15 months
|
3.2%
1/31 • Number of events 1 • 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place