Trial Outcomes & Findings for Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis (NCT NCT00041756)
NCT ID: NCT00041756
Last Updated: 2011-11-08
Results Overview
The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
395 participants
Primary outcome timeframe
baseline and 12 months
Results posted on
2011-11-08
Participant Flow
Participant milestones
| Measure |
Placebo Tablet
Placebo tablet dosed BID
|
25 mg PG-530742
25 mg PG-530742 dosed BID
|
50 mg PG-530742
50 mg PG-530742 dosed BID
|
100 mg PG-530742
100 mg PG-530742 dosed BID
|
200 mg PG-530742
200 mg PG-530742 dosed BID
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
80
|
79
|
80
|
79
|
|
Overall Study
COMPLETED
|
69
|
65
|
66
|
64
|
19
|
|
Overall Study
NOT COMPLETED
|
8
|
15
|
13
|
16
|
60
|
Reasons for withdrawal
| Measure |
Placebo Tablet
Placebo tablet dosed BID
|
25 mg PG-530742
25 mg PG-530742 dosed BID
|
50 mg PG-530742
50 mg PG-530742 dosed BID
|
100 mg PG-530742
100 mg PG-530742 dosed BID
|
200 mg PG-530742
200 mg PG-530742 dosed BID
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
10
|
6
|
11
|
34
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
4
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Unable to meet protocol criteria
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Data Monitoring Committee Recommendation
|
0
|
0
|
0
|
0
|
21
|
Baseline Characteristics
Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Placebo Tablet
n=77 Participants
Placebo tablet dosed BID
|
25 mg PG-530742
n=80 Participants
25 mg PG-530742 dosed BID
|
50 mg PG-530742
n=79 Participants
50 mg PG-530742 dosed BID
|
100 mg PG-530742
n=80 Participants
100 mg PG-530742 dosed BID
|
200 mg PG-530742
n=79 Participants
200 mg PG-530742 dosed BID
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
62.0 years
STANDARD_DEVIATION 0.92 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 0.86 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 0.92 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 0.95 • n=4 Participants
|
63.1 years
STANDARD_DEVIATION 0.80 • n=21 Participants
|
62.6 years
STANDARD_DEVIATION 0.40 • n=8 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
281 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
114 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian Oriental
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
77 participants
n=5 Participants
|
79 participants
n=7 Participants
|
77 participants
n=5 Participants
|
75 participants
n=4 Participants
|
76 participants
n=21 Participants
|
384 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
8 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis. analysis.
The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.
Outcome measures
| Measure |
Placebo Tablet
n=71 Participants
Placebo tablet dosed BID
|
25 mg PG-530742
n=66 Participants
25 mg PG-530742 dosed BID
|
50 mg PG-530742
n=67 Participants
50 mg PG-530742 dosed BID
|
100 mg PG-530742
n=69 Participants
100 mg PG-530742 dosed BID
|
200 mg PG-530742
n=52 Participants
200 mg PG-530742 dosed BID
|
|---|---|---|---|---|---|
|
Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment
|
-0.1361 mm
Standard Error 0.0627
|
-0.0442 mm
Standard Error 0.0624
|
-0.2261 mm
Standard Error 0.0650
|
-0.2000 mm
Standard Error 0.0650
|
-0.1916 mm
Standard Error 0.0723
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.
The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)
Outcome measures
| Measure |
Placebo Tablet
n=67 Participants
Placebo tablet dosed BID
|
25 mg PG-530742
n=61 Participants
25 mg PG-530742 dosed BID
|
50 mg PG-530742
n=62 Participants
50 mg PG-530742 dosed BID
|
100 mg PG-530742
n=62 Participants
100 mg PG-530742 dosed BID
|
200 mg PG-530742
n=30 Participants
200 mg PG-530742 dosed BID
|
|---|---|---|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year
|
-9.1 Scores on a scale
Standard Error 2.81
|
-6.7 Scores on a scale
Standard Error 2.78
|
-10.0 Scores on a scale
Standard Error 2.88
|
-5.8 Scores on a scale
Standard Error 2.92
|
-9.3 Scores on a scale
Standard Error 3.96
|
Adverse Events
Placebo Tablet
Serious events: 8 serious events
Other events: 37 other events
Deaths: 0 deaths
25 mg PG-530742
Serious events: 7 serious events
Other events: 41 other events
Deaths: 0 deaths
50 mg PG-530742
Serious events: 12 serious events
Other events: 34 other events
Deaths: 0 deaths
100 mg PG-530742
Serious events: 10 serious events
Other events: 43 other events
Deaths: 0 deaths
200 mg PG-530742
Serious events: 17 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Tablet
n=77 participants at risk
Placebo tablet dosed BID
|
25 mg PG-530742
n=80 participants at risk
25 mg PG-530742 dosed BID
|
50 mg PG-530742
n=79 participants at risk
50 mg PG-530742 dosed BID
|
100 mg PG-530742
n=80 participants at risk
100 mg PG-530742 dosed BID
|
200 mg PG-530742
n=79 participants at risk
200 mg PG-530742 dosed BID
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
2.6%
2/77 • Number of events 2
|
3.8%
3/80 • Number of events 3
|
1.3%
1/79 • Number of events 1
|
5.0%
4/80 • Number of events 4
|
3.8%
3/79 • Number of events 3
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia NOS
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
|
Cardiac disorders
Cardiac failure NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
2.5%
2/79 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/77 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Localised Osteoarthritis
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Cardiac disorders
Atioventricular block NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Cardiac disorders
Tachycardia NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/77 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Eye disorders
Cataract
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Eye disorders
Cataract unilateral
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Gastrointestinal disorders
Diverticulitis NOS
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Gastrointestinal disorders
Duodenal erosions
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Gastric erosions
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Gastrointestinal disorders
Appendicitis perforated
|
1.3%
1/77 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Fibrosis NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Gastrointestinal disorders
Pharyngitis
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tibia fracture
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Tendon rupture
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Humerus fracture
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Blood and lymphatic system disorders
Biopsy lymph gland abnormal
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Blood and lymphatic system disorders
Hypoglycaemia NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Arthritis NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Toe deformities NOS
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc herniation
|
1.3%
1/77 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Skin and subcutaneous tissue disorders
Dupuytren's contracture
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Fibrositis
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Nervous system disorders
Pain in extremity
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Spondylosis
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer NOS
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/77
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Vascular disorders
Vertegrobasilar insufficiency
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/77
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
|
Renal and urinary disorders
Renal failure NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Renal and urinary disorders
Urethral stricture
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatic hypertrophy
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
1.2%
1/80 • Number of events 1
|
0.00%
0/79
|
|
Vascular disorders
Haemorrhage NOS
|
0.00%
0/77
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
1.3%
1/79 • Number of events 1
|
|
Vascular disorders
Hypertension NOS
|
1.3%
1/77 • Number of events 1
|
0.00%
0/80
|
0.00%
0/79
|
0.00%
0/80
|
0.00%
0/79
|
Other adverse events
| Measure |
Placebo Tablet
n=77 participants at risk
Placebo tablet dosed BID
|
25 mg PG-530742
n=80 participants at risk
25 mg PG-530742 dosed BID
|
50 mg PG-530742
n=79 participants at risk
50 mg PG-530742 dosed BID
|
100 mg PG-530742
n=80 participants at risk
100 mg PG-530742 dosed BID
|
200 mg PG-530742
n=79 participants at risk
200 mg PG-530742 dosed BID
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Renal and urinary disorders
|
5.2%
4/77 • Number of events 4
|
1.2%
1/80 • Number of events 1
|
2.5%
2/79 • Number of events 2
|
3.8%
3/80 • Number of events 3
|
6.3%
5/79 • Number of events 5
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders (Overall)
|
2.6%
2/77 • Number of events 2
|
2.5%
2/80 • Number of events 2
|
3.8%
3/79 • Number of events 4
|
0.00%
0/80
|
3.8%
3/79 • Number of events 3
|
|
Cardiac disorders
Cardiac disorders (Overall)
|
1.3%
1/77 • Number of events 1
|
5.0%
4/80 • Number of events 6
|
10.1%
8/79 • Number of events 8
|
8.8%
7/80 • Number of events 10
|
5.1%
4/79 • Number of events 5
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders (Overall)
|
1.3%
1/77 • Number of events 1
|
0.00%
0/80
|
2.5%
2/79 • Number of events 2
|
5.0%
4/80 • Number of events 4
|
1.3%
1/79 • Number of events 1
|
|
Eye disorders
Eye disorders (Overall)
|
3.9%
3/77 • Number of events 6
|
3.8%
3/80 • Number of events 4
|
6.3%
5/79 • Number of events 6
|
2.5%
2/80 • Number of events 2
|
3.8%
3/79 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders (Overall)
|
18.2%
14/77 • Number of events 31
|
17.5%
14/80 • Number of events 21
|
19.0%
15/79 • Number of events 25
|
20.0%
16/80 • Number of events 34
|
24.1%
19/79 • Number of events 37
|
|
General disorders
General disorders and administration site conditions (Overall)
|
6.5%
5/77 • Number of events 7
|
13.8%
11/80 • Number of events 14
|
15.2%
12/79 • Number of events 13
|
11.2%
9/80 • Number of events 11
|
24.1%
19/79 • Number of events 20
|
|
Infections and infestations
Infections and infestation (Overall)
|
28.6%
22/77 • Number of events 37
|
32.5%
26/80 • Number of events 40
|
20.3%
16/79 • Number of events 18
|
30.0%
24/80 • Number of events 35
|
20.3%
16/79 • Number of events 22
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications (Overall)
|
7.8%
6/77 • Number of events 9
|
5.0%
4/80 • Number of events 4
|
7.6%
6/79 • Number of events 7
|
8.8%
7/80 • Number of events 7
|
6.3%
5/79 • Number of events 5
|
|
Investigations
Investigations (Overall)
|
11.7%
9/77 • Number of events 14
|
20.0%
16/80 • Number of events 31
|
15.2%
12/79 • Number of events 19
|
11.2%
9/80 • Number of events 16
|
12.7%
10/79 • Number of events 23
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders (Overall)
|
1.3%
1/77 • Number of events 1
|
2.5%
2/80 • Number of events 2
|
3.8%
3/79 • Number of events 3
|
3.8%
3/80 • Number of events 4
|
2.5%
2/79 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders (Overall)
|
48.1%
37/77 • Number of events 91
|
51.2%
41/80 • Number of events 104
|
43.0%
34/79 • Number of events 85
|
53.8%
43/80 • Number of events 135
|
55.7%
44/79 • Number of events 154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (Overall)
|
2.6%
2/77 • Number of events 2
|
2.5%
2/80 • Number of events 2
|
5.1%
4/79 • Number of events 4
|
2.5%
2/80 • Number of events 3
|
0.00%
0/79
|
|
Nervous system disorders
Nervous system disorders (Overall)
|
9.1%
7/77 • Number of events 8
|
15.0%
12/80 • Number of events 16
|
12.7%
10/79 • Number of events 15
|
8.8%
7/80 • Number of events 7
|
8.9%
7/79 • Number of events 10
|
|
Nervous system disorders
Psychiatric disorders
|
5.2%
4/77 • Number of events 4
|
2.5%
2/80 • Number of events 3
|
3.8%
3/79 • Number of events 4
|
1.2%
1/80 • Number of events 1
|
5.1%
4/79 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.9%
3/77 • Number of events 3
|
12.5%
10/80 • Number of events 12
|
7.6%
6/79 • Number of events 8
|
8.8%
7/80 • Number of events 13
|
8.9%
7/79 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders (Overall)
|
9.1%
7/77 • Number of events 9
|
10.0%
8/80 • Number of events 9
|
10.1%
8/79 • Number of events 10
|
2.5%
2/80 • Number of events 3
|
2.5%
2/79 • Number of events 2
|
|
Vascular disorders
Vascular disorders
|
10.4%
8/77 • Number of events 9
|
8.8%
7/80 • Number of events 7
|
3.8%
3/79 • Number of events 3
|
7.5%
6/80 • Number of events 7
|
8.9%
7/79 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER