Trial Outcomes & Findings for The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease (NCT NCT00371293)
NCT ID: NCT00371293
Last Updated: 2017-04-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
181 participants
Primary outcome timeframe
Measured at Baseline and Week 24
Results posted on
2017-04-05
Participant Flow
Participant milestones
| Measure |
CPAP
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
Combination
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
61
|
62
|
|
Overall Study
COMPLETED
|
48
|
42
|
46
|
|
Overall Study
NOT COMPLETED
|
10
|
19
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Obesity and Obstructive Sleep Apnea on Inflammation and Heart Disease
Baseline characteristics by cohort
| Measure |
CPAP
n=58 Participants
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss
n=61 Participants
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
Combination
n=62 Participants
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 10 • n=93 Participants
|
48.3 years
STANDARD_DEVIATION 10 • n=4 Participants
|
49 years
STANDARD_DEVIATION 10 • n=27 Participants
|
49 years
STANDARD_DEVIATION 10 • n=483 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
104 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=93 Participants
|
61 participants
n=4 Participants
|
62 participants
n=27 Participants
|
181 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 24Outcome measures
| Measure |
CPAP - Adherent
n=48 Participants
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss - Adherent
n=42 Participants
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
Combination - Adherent
n=46 Participants
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
|---|---|---|---|
|
Inflammation
|
-11.47 percentage of change in crp at week 24
Interval -26.09 to 6.03
|
-37.45 percentage of change in crp at week 24
Interval -49.23 to -22.94
|
-32.66 percentage of change in crp at week 24
Interval -47.14 to -14.22
|
SECONDARY outcome
Timeframe: Measured at Baseline and Week 24Assessed using the frequently sampled intravenous glucose tolerance test (FSIGTT) which evaluates blood glucose and insulin levels. Insulin sensitivity is estimated using the Bergman's minimal model.
Outcome measures
| Measure |
CPAP - Adherent
n=48 Participants
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss - Adherent
n=42 Participants
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
Combination - Adherent
n=46 Participants
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
|---|---|---|---|
|
Change in Insulin Resistance (Insulin Sensitivity Index, x10-4/Min-1/μU/ml)
|
.06 x10-4/min-1/μU/ml
Interval -0.34 to 0.46
|
.43 x10-4/min-1/μU/ml
Interval -0.04 to 0.9
|
.74 x10-4/min-1/μU/ml
Interval 0.24 to 1.23
|
SECONDARY outcome
Timeframe: Measured at Baseline and Week 24Outcome measures
| Measure |
CPAP - Adherent
n=48 Participants
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss - Adherent
n=42 Participants
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
Combination - Adherent
n=46 Participants
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
|---|---|---|---|
|
Change in LDL Cholesterol Levels
|
-3.76 mg/dL
Interval -10.08 to 2.55
|
-9.25 mg/dL
Interval -16.87 to -1.6
|
-13.54 mg/dL
Interval -22.03 to -5.05
|
SECONDARY outcome
Timeframe: Measured at Baseline and Week 24Outcome measures
| Measure |
CPAP - Adherent
n=48 Participants
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss - Adherent
n=42 Participants
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
Combination - Adherent
n=46 Participants
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
|---|---|---|---|
|
Change in Triglyceride Levels
|
-7.1 mg/dL
Interval -24.2 to 10.0
|
-23.2 mg/dL
Interval -43.8 to -2.6
|
-53 mg/dL
Interval -76.0 to -30.2
|
SECONDARY outcome
Timeframe: Measured at Baseline and Week 24Outcome measures
| Measure |
CPAP - Adherent
n=48 Participants
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss - Adherent
n=42 Participants
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
Combination - Adherent
n=46 Participants
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
|---|---|---|---|
|
Change in HDL Cholesterol Levels
|
-0.62 mg/dL
Interval -2.74 to 1.5
|
0.71 mg/dL
Interval -1.85 to 3.27
|
0.49 mg/dL
Interval -2.37 to 3.34
|
Adverse Events
CPAP
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Combination
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Weight Loss
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPAP
n=58 participants at risk
Participants will receive CPAP therapy.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Combination
n=62 participants at risk
Participants will receive CPAP therapy and take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.
|
Weight Loss
n=61 participants at risk
Participants will take part in a weight loss program.
Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.4%
2/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
10.3%
6/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
6.5%
4/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
13.1%
8/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nostril Irritation
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
6.5%
4/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of Respiratory Allergy Symptoms
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Nervous system disorders
"Shakiness" After IVGTT
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
3.2%
2/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Burning Sensation after IVGTT
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Lump at site of IV
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Bruising/Tenderness- IV
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Gastrointestinal disorders
Vomited during IVGTT
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash from Lead
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
4.8%
3/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Cardiac disorders
High Blood Pressure
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Cardiac disorders
Chest Pain
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
3.2%
2/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Ear and labyrinth disorders
Laryngitis
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Endocrine disorders
Type II Diabetes
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
3.2%
2/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
3.2%
2/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
General disorders
Self Committed to Hospital
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis of Shoulder
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Cardiac disorders
Swelling in legs and ankles
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Surgical and medical procedures
Knee Replacement Surgery
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Surgical and medical procedures
Rotator Cuff Surgery
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Cardiac disorders
Leg Cramps
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in ankle/ lower back
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
General disorders
Dehydration
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Sprained Wrist/ Bruised Knee
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
General disorders
Right Flank Pain
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Surgical and medical procedures
Tooth Extraction and Implant
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Renal and urinary disorders
Possible Urinary Tract Infection
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
New diagnosis of fibromyalgia
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Gastrointestinal disorders
Intestinal Cramping
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Pain
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Ankle Injury
|
1.7%
1/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
|
Renal and urinary disorders
Abdominal Pain/ Kidney Stone
|
0.00%
0/58
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
1.6%
1/62
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
0.00%
0/61
Clustered data collection. Data on separate Adverse Event Terms not available. All adverse events were non serious so they are reported under Other Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place