Trial Outcomes & Findings for Effect of Steroid Injections in a Knee With Osteoarthritis (NCT NCT01230424)
NCT ID: NCT01230424
Last Updated: 2017-07-31
Results Overview
Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner). Missing data were imputed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Baseline to 2 years
Results posted on
2017-07-31
Participant Flow
Participant milestones
| Measure |
Triamcinolone Acetonide
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections.
|
Sodium Chloride
Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
70
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Steroid Injections in a Knee With Osteoarthritis
Baseline characteristics by cohort
| Measure |
Triamcinolone Acetonide
n=70 Participants
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections.
|
Sodium Chloride
n=70 Participants
Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
70 participants
n=7 Participants
|
140 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner). Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)
|
-0.21 mm
Interval -0.29 to -0.14
|
-0.10 mm
Interval -0.16 to -0.04
|
PRIMARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Pain subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Pain subscale score was used for this outcome measure. The Pain subscale consists of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. Higher scores represent higher levels of pain, whereas lower scores represent lower levels of pain. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.
|
-1.2 units on a scale
Interval -1.9 to -0.6
|
-1.9 units on a scale
Interval -2.5 to -1.2
|
SECONDARY outcome
Timeframe: Baseline to 2 years.Population: All individuals were included in analysis, which was performed on multiply imputed data.
Change in volume of peri-articular bone marrow lesions measured on knee MRI on the log scale. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.
|
0.9 log mm^3
Interval -0.3 to 2.1
|
1.1 log mm^3
Interval -0.3 to 2.6
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Change in effusion volume measured on knee MRI on the log scale. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Effusion Volume Measured on Knee MRI.
|
-0.1 log mm^3
Interval -0.4 to 0.3
|
-0.3 log mm^3
Interval -0.6 to -0.1
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Change in area of denudation measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
|
0.4 mm^2
Interval 0.1 to 0.8
|
0.4 mm^2
Interval 0.2 to 0.7
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Change in volumetric cartilage damage index (CDI) measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).
|
-133.7 mm^3
Interval -177.4 to -89.9
|
-72.4 mm^3
Interval -114.2 to -30.7
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Physical Function subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Physical Function subscale score was used for this outcome measure. The Physical Function subscale consists of 17 items, each ranging from 0 to 4, making the total Function subscore 0 to 68. Higher scores represent higher levels of difficulty performing daily activities, whereas lower scores represent lower levels of difficulty performing daily activities. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.
|
-4.1 units on a scale
Interval -7.4 to -0.8
|
-5.1 units on a scale
Interval -8.1 to -2.2
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Stiffness subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Stiffness subscale score was used for this outcome measure. The Stiffness subscale consists of two items, each ranging from 0 to 4, making the total Stiffness subscore 0 to 8. Higher scores represent higher levels of stiffness, whereas lower scores represent lower levels of stiffness. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.
|
-0.6 units on a scale
Interval -1.1 to -0.1
|
-0.5 units on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
The response to the question, "Considering all the ways your knee affects you, how much pain are you having today?", was measured and the change in the scoring was evaluated. The Patient's Global Assessment (PGA) is measured on a scale of 0 to 100 millimeters. Higher scores represent a higher level of disease activity or a worse global health. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Patient's Global Assessment (Visual Analogue Scale).
|
-2.7 mm
Interval -11.9 to 6.6
|
-7.6 mm
Interval -15.4 to 0.2
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Change in time (seconds) to complete a twenty-meter walk. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Time to Complete a Twenty-meter Walk.
|
-0.3 seconds
Interval -1.0 to 0.4
|
0.1 seconds
Interval -0.6 to 0.9
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: All individuals were included in analysis, which was performed on multiply imputed data.
Change in time (seconds) to complete 5 chair stands. Missing data were imputed.
Outcome measures
| Measure |
Triamcinolone Acetonide 40mg
n=70 Participants
All participants received 40 mg of triamcinolone acetonide into the study knee joint every 12 weeks for a total of 8 injections.
|
0.9% Sodium Chloride
n=70 Participants
All participants received 0.9% Sodium chloride injection given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Change in Time to Complete 5 Chair Stands.
|
-1.1 seconds
Interval -3.5 to 1.2
|
-1.2 seconds
Interval -3.6 to 1.1
|
Adverse Events
Triamcinolone Acetonide
Serious events: 15 serious events
Other events: 48 other events
Deaths: 0 deaths
Sodium Chloride
Serious events: 27 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triamcinolone Acetonide
n=70 participants at risk
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections.
|
Sodium Chloride
n=70 participants at risk
Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma excerbation
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver and bone cancer
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Vascular disorders
Hypertension
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
2/70 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
1.4%
1/70 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoid
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Surgical and medical procedures
Foot surgery
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood clot in leg
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Fractured humerus
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
1.4%
1/70 • Number of events 1
|
2.9%
2/70 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign cyst surgical removal
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Aortic Valve Stenosis
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Erysipelas
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma surgical removal
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
General disorders
fever
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Infra-hisian block
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/70 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/70 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Achilles Tendon tear
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Suddden Death
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Ear and labyrinth disorders
Cholesteatoma
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Epigastric pain
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Staphylococcal infection
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendiceal mucinous neoplasm
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Metformin toxicity
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Alcohol withdrawal
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Acid reflux
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Breast cancer
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal carcinoma insitu
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Cardiac disorders
Weakness and chest pain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
Other adverse events
| Measure |
Triamcinolone Acetonide
n=70 participants at risk
40 mg into the study knee joint every 12 weeks for a total of 8 injections.
Triamcinolone Acetonide: 40 mg into the study knee joint every 12 weeks for a total of 8 injections.
|
Sodium Chloride
n=70 participants at risk
Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
0.9% Sodium Chloride Injection as Placebo: Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Dog bites on left wrist
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.9%
2/70 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia and Gastritis
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.3%
3/70 • Number of events 3
|
5.7%
4/70 • Number of events 4
|
|
Metabolism and nutrition disorders
Increase in atorvastatin dosage
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Gastrophageal reflux disease
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Flu-like symptoms
|
8.6%
6/70 • Number of events 6
|
14.3%
10/70 • Number of events 10
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
8.6%
6/70 • Number of events 7
|
4.3%
3/70 • Number of events 3
|
|
Renal and urinary disorders
Chronic Kidney Disease-Stage III
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
3/70 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Broken Toe
|
2.9%
2/70 • Number of events 2
|
0.00%
0/70
|
|
Eye disorders
Conjunctivitis
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Eye disorders
Eye inflammation
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Bladder infections
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Swollen left knee
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Sinus Infection
|
4.3%
3/70 • Number of events 4
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Shingles
|
2.9%
2/70 • Number of events 2
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
1.4%
1/70 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest cold
|
14.3%
10/70 • Number of events 11
|
17.1%
12/70 • Number of events 13
|
|
Injury, poisoning and procedural complications
Right foot pain
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Injury, poisoning and procedural complications
Left (index) knee sprain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Back pain
|
2.9%
2/70 • Number of events 2
|
5.7%
4/70 • Number of events 4
|
|
Eye disorders
Glaucoma
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid nodule
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Walking pneumonia
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Psychiatric disorders
Anxiety attack
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Fractured rib
|
0.00%
0/70
|
4.3%
3/70 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruised ribs
|
1.4%
1/70 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus inflammation
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Immune system disorders
Reaction to shingle vaccine
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Established hypertension
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Vascular disorders
Transient hypertension
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Sprained wrist
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
4.3%
3/70 • Number of events 4
|
4.3%
3/70 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Increased neck and facial muscle pain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Reproductive system and breast disorders
Perimenopause and ovarian cyst flare
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Bursitis in hips
|
1.4%
1/70 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
2.9%
2/70 • Number of events 2
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Left foot pain
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Stomach virus
|
1.4%
1/70 • Number of events 2
|
0.00%
0/70
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Stomach pain and vomitting
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Venous injury
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Closed head injury with scalp laceration
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Infective conjunctivitis
|
0.00%
0/70
|
1.4%
1/70 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Head cold
|
2.9%
2/70 • Number of events 2
|
7.1%
5/70 • Number of events 5
|
|
Nervous system disorders
Diffuse joint pain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Herniated Disc
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Chipped Tooth
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Otitis Media
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Gout flare in big toe
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Immune system disorders
Erythema-facial
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Cardiac disorders
Chest pain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left ankle pain and swelling
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Respiratory, thoracic and mediastinal disorders
Acute exacerbation of asthma
|
2.9%
2/70 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Bacterial infection
|
1.4%
1/70 • Number of events 2
|
2.9%
2/70 • Number of events 2
|
|
Cardiac disorders
Syncope
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Yeast Infection
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
General disorders
Fever
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Bronchial infection
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Cold symptoms
|
11.4%
8/70 • Number of events 8
|
5.7%
4/70 • Number of events 5
|
|
Renal and urinary disorders
Hematuria
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Wound infection
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Food poisoning
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
General disorders
Pain - abdominal and lower back
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinovirus
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left (index) knee tightness
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Diarrhea
|
1.4%
1/70 • Number of events 1
|
2.9%
2/70 • Number of events 3
|
|
General disorders
Injection site pain
|
5.7%
4/70 • Number of events 4
|
2.9%
2/70 • Number of events 2
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Renal and urinary disorders
Benign Prostatic hyperplasia
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Left ulna fracture
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/70 • Number of events 1
|
4.3%
3/70 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
2/70 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right (index) knee joint effusion
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Injury, poisoning and procedural complications
Body pain
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Psychiatric disorders
Insomnia and anxiety
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Right knee burning sensation
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Superficial knee scrape & laceration
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
4.3%
3/70 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Right (non-index) hamstring strain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Infections and infestations
Parasite (nematode) in left eye
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Left arm contusion
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • Number of events 1
|
2.9%
2/70 • Number of events 2
|
|
Infections and infestations
Viral Infection
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Torn ACL
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/70
|
2.9%
2/70 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Right (index) knee joint discomfort
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
1/70 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Locked right (index) knee
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
2.9%
2/70 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sciatica flare
|
2.9%
2/70 • Number of events 2
|
0.00%
0/70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pre-cancerous mole-left forearm
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Post-surgical incision site infection - left forearm
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Blood and lymphatic system disorders
Polycythemia vera
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Torn meniscus - left knee
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Immune system disorders
Allergic bronchitis
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Gastrointestinal disorders
Hiatal hernia
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Left heel fracture
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Cellulitis - right hand
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Right (index) knee pain & swelling
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Left (index) knee swelling
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
fungal infection
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Streptococcal pharyngitis
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Musculoskeletal and connective tissue disorders
Strained muscle - back
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine fibroid
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome - bilateral hands
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Infections and infestations
Lung infection
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Knee contusion
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dislocated right middle finger
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left shoulder strain
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Nervous system disorders
Headache
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Synovial cyst - lumbar spine
|
1.4%
1/70 • Number of events 1
|
0.00%
0/70
|
|
Injury, poisoning and procedural complications
Pain - right shoulder
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear - right shoulder
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Shoulder sprain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
General disorders
Right leg pain
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising - left wrist
|
0.00%
0/70
|
1.4%
1/70 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place