Trial Outcomes & Findings for Optimizing Protein Intake in Older Americans With Mobility Limitations (NCT NCT01275365)
NCT ID: NCT01275365
Last Updated: 2021-07-29
Results Overview
Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
92 participants
Primary outcome timeframe
6 months from baseline
Results posted on
2021-07-29
Participant Flow
Participant milestones
| Measure |
Placebo/Low Protein
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
21
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo/Low Protein
n=24 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=24 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=22 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=22 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 4.2 • n=24 Participants
|
73.5 years
STANDARD_DEVIATION 5.7 • n=24 Participants
|
71.0 years
STANDARD_DEVIATION 3.6 • n=22 Participants
|
76.0 years
STANDARD_DEVIATION 7.9 • n=22 Participants
|
73.0 years
STANDARD_DEVIATION 5.8 • n=92 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
92 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
24 participants
n=24 Participants
|
22 participants
n=22 Participants
|
22 participants
n=22 Participants
|
92 participants
n=92 Participants
|
|
Body weight
|
95.3 kg
STANDARD_DEVIATION 12.5 • n=24 Participants
|
90.2 kg
STANDARD_DEVIATION 15.8 • n=24 Participants
|
94.4 kg
STANDARD_DEVIATION 17.6 • n=22 Participants
|
87.2 kg
STANDARD_DEVIATION 18.3 • n=22 Participants
|
91.8 kg
STANDARD_DEVIATION 16.2 • n=92 Participants
|
|
Body Mass Index (BMI)
|
31.1 kg/m^2
STANDARD_DEVIATION 4.2 • n=24 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 4.6 • n=24 Participants
|
31.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=22 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 5.0 • n=22 Participants
|
30.3 kg/m^2
STANDARD_DEVIATION 4.9 • n=92 Participants
|
|
Diabetes
|
4 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=22 Participants
|
14 Participants
n=92 Participants
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)
Outcome measures
| Measure |
Placebo/Low Protein
n=21 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=21 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=17 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=19 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)
|
0.14 kg
Standard Error 0.31
|
0.74 kg
Standard Error 0.33
|
4.43 kg
Standard Error 0.48
|
4.13 kg
Standard Error 0.42
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities.
Outcome measures
| Measure |
Placebo/Low Protein
n=13 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=9 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=14 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=13 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of Maximal Voluntary Strength
Maximal voluntary strength in leg press
|
134.6 newton
Standard Error 46.4
|
156.0 newton
Standard Error 89.1
|
201.8 newton
Standard Error 44.4
|
191.4 newton
Standard Error 38.0
|
|
Change of Maximal Voluntary Strength
Maximal voluntary strength in chest press
|
41.5 newton
Standard Error 12.3
|
16.6 newton
Standard Error 9.2
|
64.5 newton
Standard Error 11.9
|
59.3 newton
Standard Error 11.3
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.
Outcome measures
| Measure |
Placebo/Low Protein
n=12 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=9 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=15 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=12 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of Leg Press Power
|
26.9 watts
Standard Error 17.0
|
96.9 watts
Standard Error 19.6
|
61.5 watts
Standard Error 22.2
|
81.7 watts
Standard Error 16.1
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance
Outcome measures
| Measure |
Placebo/Low Protein
n=16 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=14 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=16 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=18 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of 6-minute Walking Distance
|
44.2 meters
Standard Error 17.9
|
49.9 meters
Standard Error 14.2
|
38.2 meters
Standard Error 21.9
|
25.5 meters
Standard Error 11.5
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry. Physical Function was evaluated using two tests of stair climb power using an indoor 12-step staircase. One test consisted of ascending the 12-steps as rapidly as possible without running (unloaded stair climb) while the second test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags (loaded stair climb). Time to ascend the stairs was measured electronically with a digital clock and switch mats placed at the base of the steps and on the 12th step. Power in watts is calculated by the following: \[body weight (kilograms) \* distance (meters)/ (time/60)\] /6.12.
Outcome measures
| Measure |
Placebo/Low Protein
n=14 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=11 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=16 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=15 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of Stair Climbing Tests
Unloaded
|
50.8 watts
Standard Error 19.2
|
55.4 watts
Standard Error 14.2
|
53.2 watts
Standard Error 17.5
|
4.2 watts
Standard Error 13.5
|
|
Change of Stair Climbing Tests
Loaded
|
56.8 watts
Standard Error 15.7
|
83.7 watts
Standard Error 28.5
|
56.6 watts
Standard Error 18.8
|
26.9 watts
Standard Error 14.3
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry. Physical Function was evaluated using test of 50-meter loaded walking speed. The test required participants to carry a load equivalent to 20% of their baseline body weight evenly distributed in two canvas tote bags. Time was measured electronically with a digital clock. Speed in meters per second is calculated by the following: 50/time.
Outcome measures
| Measure |
Placebo/Low Protein
n=11 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=13 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=15 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=13 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of 50-meter Loaded Walking Test
|
0.15 meters per second
Standard Error 0.04
|
0.11 meters per second
Standard Error 0.05
|
0.06 meters per second
Standard Error 0.05
|
0.08 meters per second
Standard Error 0.04
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance.
Outcome measures
| Measure |
Placebo/Low Protein
n=21 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=21 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=17 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=19 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)
|
-1.4 units on a scale
Standard Error 3.1
|
-5.5 units on a scale
Standard Error 5.3
|
2.1 units on a scale
Standard Error 2.8
|
-2.9 units on a scale
Standard Error 2.9
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance.
Outcome measures
| Measure |
Placebo/Low Protein
n=21 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=21 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=17 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=19 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of Psychological Well Being Index (PGWBI)
|
-0.56 units on a scale
Standard Error 1.53
|
1.17 units on a scale
Standard Error 1.77
|
0.32 units on a scale
Standard Error 2.08
|
2.68 units on a scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.
Outcome measures
| Measure |
Placebo/Low Protein
n=21 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=21 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=17 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=19 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
|
0.14 units on a scale
Standard Error 1.56
|
-0.14 units on a scale
Standard Error 1.41
|
-0.53 units on a scale
Standard Error 1.39
|
1.05 units on a scale
Standard Error 1.16
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: All randomized and treated participants with data available at the given time-point.
The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity.
Outcome measures
| Measure |
Placebo/Low Protein
n=21 Participants
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=20 Participants
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=17 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=19 Participants
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Change of Derogatis Affective Balance Scale (DABS)
Affects Expressiveness Index (AEI)
|
0.65 units on a scale
Standard Error 3.54
|
1.45 units on a scale
Standard Error 1.96
|
-0.50 units on a scale
Standard Error 2.51
|
-3.17 units on a scale
Standard Error 1.99
|
|
Change of Derogatis Affective Balance Scale (DABS)
Positive Total score (PTOT)
|
1.38 units on a scale
Standard Error 2.09
|
2.10 units on a scale
Standard Error 1.70
|
0.69 units on a scale
Standard Error 1.68
|
1.89 units on a scale
Standard Error 1.29
|
|
Change of Derogatis Affective Balance Scale (DABS)
Negative Total score (NTOT)
|
-1.50 units on a scale
Standard Error 2.03
|
-0.65 units on a scale
Standard Error 1.36
|
-0.88 units on a scale
Standard Error 2.85
|
-5.53 units on a scale
Standard Error 1.47
|
Adverse Events
Placebo/Low Protein
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo/High Protein
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Testosterone/Low Protein
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Testosterone/High Protein
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Low Protein
n=24 participants at risk
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=24 participants at risk
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=22 participants at risk
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=22 participants at risk
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
Other adverse events
| Measure |
Placebo/Low Protein
n=24 participants at risk
Placebo injections weekly; 0.8 g/kg/day protein
|
Placebo/High Protein
n=24 participants at risk
Placebo injections weekly; 1.3 g/kg/day protein
|
Testosterone/Low Protein
n=22 participants at risk
Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
Testosterone/High Protein
n=22 participants at risk
Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein
Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Cardiac disorders
Chest pain
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Cardiac disorders
Pulmonary congestion
|
0.00%
0/24 • 6 months
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Ear and labyrinth disorders
Ear infection
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Eye disorders
Cataract
|
0.00%
0/24 • 6 months
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Eye disorders
Eye irritation
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
18.2%
4/22 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
9.1%
2/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
9.1%
2/22 • 6 months
|
9.1%
2/22 • Number of events 4 • 6 months
|
|
Gastrointestinal disorders
Flatulence, bloating and distension
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • 6 months
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Fatigue
|
4.2%
1/24 • 6 months
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Inflammation
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
General disorders
Malaise
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Immune system disorders
Asthma
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Immune system disorders
Seasonal allergy
|
4.2%
1/24 • 6 months
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Infections and infestations
Bronchitis
|
4.2%
1/24 • 6 months
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Cellulitis
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Infections and infestations
Conjunctivitis
|
8.3%
2/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Pheumonia
|
4.2%
1/24 • 6 months
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Infections and infestations
Urinary tract infections
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Epicodylitis
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • Number of events 2 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Injection site pain
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • Number of events 2 • 6 months
|
0.00%
0/22 • 6 months
|
|
Investigations
Biopsy skin
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Investigations
Prostatic specific antigen abnormal
|
8.3%
2/24 • 6 months
|
8.3%
2/24 • 6 months
|
4.5%
1/22 • 6 months
|
9.1%
2/22 • 6 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.2%
1/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
2/24 • Number of events 4 • 6 months
|
4.2%
1/24 • Number of events 2 • 6 months
|
9.1%
2/22 • 6 months
|
9.1%
2/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
6/24 • 6 months
|
4.2%
1/24 • 6 months
|
18.2%
4/22 • 6 months
|
13.6%
3/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
9.1%
2/22 • Number of events 4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
1/24 • Number of events 2 • 6 months
|
8.3%
2/24 • 6 months
|
9.1%
2/22 • 6 months
|
4.5%
1/22 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
12.5%
3/24 • 6 months
|
8.3%
2/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
8.3%
2/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/24 • 6 months
|
12.5%
3/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
13.6%
3/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • 6 months
|
4.2%
1/24 • Number of events 2 • 6 months
|
4.5%
1/22 • 6 months
|
13.6%
3/22 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermal cyst
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
13.6%
3/22 • Number of events 6 • 6 months
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
9.1%
2/22 • 6 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Nervous system disorders
Gait disturbance
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
9.1%
2/22 • 6 months
|
|
Psychiatric disorders
Depression
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
8.3%
2/24 • 6 months
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/24 • 6 months
|
8.3%
2/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • 6 months
|
18.2%
4/22 • 6 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Renal and urinary disorders
Urine flow decreased
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Reproductive system and breast disorders
Prostatic asymmetry
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Reproductive system and breast disorders
Prostatitis
|
8.3%
2/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
3/24 • 6 months
|
4.2%
1/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Ifluenza
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Musculoskeletal chest pain
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • 6 months
|
4.2%
1/24 • 6 months
|
4.5%
1/22 • Number of events 2 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
8.3%
2/24 • 6 months
|
8.3%
2/24 • 6 months
|
9.1%
2/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
4.2%
1/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
8.3%
2/24 • Number of events 3 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
12.5%
3/24 • 6 months
|
4.2%
1/24 • 6 months
|
18.2%
4/22 • 6 months
|
13.6%
3/22 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • 6 months
|
8.3%
2/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
4.5%
1/22 • 6 months
|
0.00%
0/22 • 6 months
|
|
Vascular disorders
Flushing
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Vascular disorders
Haemorrhoidal haemorrhage
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Vascular disorders
Hot flush
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
|
Vascular disorders
Skin ulcer
|
0.00%
0/24 • 6 months
|
0.00%
0/24 • 6 months
|
0.00%
0/22 • 6 months
|
4.5%
1/22 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place