Trial Outcomes & Findings for Sulindac and Breast Density in Women at Risk of Developing Breast Cancer (NCT NCT04542135)
NCT ID: NCT04542135
Last Updated: 2026-07-17
Results Overview
The primary objective of this study is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
12 months
Results posted on
2026-07-17
Participant Flow
Participant milestones
| Measure |
Sulindac
sulindac 150 mg
|
Placebo
placebo pill
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
6 months
|
28
|
26
|
|
Overall Study
COMPLETED
|
25
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sulindac and Breast Density in Women at Risk of Developing Breast Cancer
Baseline characteristics by cohort
| Measure |
Sulindac
n=31 Participants
sulindac 150 mg
|
Placebo
n=30 Participants
placebo pill
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 Year
n=20 Participants
|
57 Year
n=20 Participants
|
60 Year
n=40 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
54 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not available
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Baseline breast density
|
23.8 percentage
n=20 Participants
|
18.5 percentage
n=20 Participants
|
22 percentage
n=40 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Linear mixed effect model for longitudinal data is used for testing the relative change in percent breast density. Participants who completed 6 months in the study and for whom percent breast density data were available were included in analysis of primary outcome.
The primary objective of this study is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value.
Outcome measures
| Measure |
Sulindac
n=28 Participants
sulindac 150 mg
|
Placebo
n=26 Participants
placebo pill
|
Placebo Alone
Participants who completed placebo pill alone without any aromatase inhibitors for 6 months
|
Placebo on Aromatase Inhibitors
Participants who completed placebo pill plus either letrozole, exemestane, or anastrozole for 6 months
|
|---|---|---|---|---|
|
Change in Percent Breast Density by MRI Between Treatment Arms
|
-4.85 Relative change (%) of percent density
Interval -11.29 to 1.59
|
-6.29 Relative change (%) of percent density
Interval -13.36 to 0.78
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The secondary outcome was assessed in the same participant population as the primary outcome.
The secondary objective of this study is to determine if sulindac at a dose of 150 mg BID for 6 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value.
Outcome measures
| Measure |
Sulindac
n=28 Participants
sulindac 150 mg
|
Placebo
n=26 Participants
placebo pill
|
Placebo Alone
Participants who completed placebo pill alone without any aromatase inhibitors for 6 months
|
Placebo on Aromatase Inhibitors
Participants who completed placebo pill plus either letrozole, exemestane, or anastrozole for 6 months
|
|---|---|---|---|---|
|
Change in Percent Breast Density by MRI Between Treatment Arms
|
1.47 Relative change (%) of percent density
Interval -4.77 to 7.71
|
-2.28 Relative change (%) of percent density
Interval -8.74 to 4.18
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The secondary outcome is assessed based on data from participants who were randomized and completed 6 months on study, including 28 out of 31 patients in sulindac arm and 26 out of 30 in placebo arm. 15 (53.6%) participants in the sulindac group were receiving AI therapy and 13 (46.4%) were not. In the placebo group, 13 participants (50%) were receiving AI therapy, and the remaining 13 (50%) were not receiving AI therapy.
The secondary objective is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control, with analyses stratified by aromatase inhibitor (AI) use. Results are reported separately for participants on AI therapy and those not on AI therapy.
Outcome measures
| Measure |
Sulindac
n=13 Participants
sulindac 150 mg
|
Placebo
n=15 Participants
placebo pill
|
Placebo Alone
n=13 Participants
Participants who completed placebo pill alone without any aromatase inhibitors for 6 months
|
Placebo on Aromatase Inhibitors
n=13 Participants
Participants who completed placebo pill plus either letrozole, exemestane, or anastrozole for 6 months
|
|---|---|---|---|---|
|
Changes in Percent Breast Density by MRI Within and Between Treatment Arms, Stratified by Use of Aromatase Inhibitors
|
-3.62 Relative change (%) of percent density
Interval -12.93 to 5.69
|
-6.02 Relative change (%) of percent density
Interval -13.7 to 1.66
|
-7.37 Relative change (%) of percent density
Interval -16.98 to 2.24
|
-5.44 Relative change (%) of percent density
Interval -14.32 to 3.44
|
Adverse Events
Sulindac
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sulindac
n=31 participants at risk
sulindac 150 mg
|
Placebo
n=30 participants at risk
placebo pill
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Infections and infestations
Appendicitis perforated
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
Other adverse events
| Measure |
Sulindac
n=31 participants at risk
sulindac 150 mg
|
Placebo
n=30 participants at risk
placebo pill
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Nervous system disorders
Anosmia
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Nervous system disorders
Dysgeusia
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Nervous system disorders
Spasticity
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Nervous system disorders
Extrapyramidal disorder
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
10.0%
3/30 • Number of events 3 • from enrollment until end of follow-up, up to 13 months
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Vascular disorders
Dizziness
|
3.2%
1/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Vascular disorders
Syncope
|
3.2%
1/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Vascular disorders
Hot flashes
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
6.5%
2/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Cardiac disorders
Sinus bradycardia
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Stomach pain
|
6.5%
2/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Constipation
|
6.5%
2/31 • Number of events 3 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Belching
|
6.5%
2/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
General disorders and administration site conditions
Edema limbs
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
General disorders and administration site conditions
Fatigue
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
General disorders and administration site conditions
Flu like symptoms
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
6.7%
2/30 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
General disorders and administration site conditions
Malaise
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
General disorders and administration site conditions
Pain of skin
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Immune system disorders
Allergic reaction
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Immune system disorders
Immune system disorders - Other
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Infections and infestations
Infections and Infestations
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Infections and infestations
Shingles
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Infections and infestations
Upper respiratory infection
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31 • Number of events 6 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Injury, poisoning and procedural complications
Hematoma
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Injury, poisoning and procedural complications
Pain in extremity
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
6.7%
2/30 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
6.7%
2/30 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
Cholesterol high
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
Investigations - Other
|
6.5%
2/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
Alkaline phosphatase increased
|
6.5%
2/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
Anemia
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
Neutrophil count decreased
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Investigations
White blood cell decreased
|
6.5%
2/31 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Metabolism and nutrition disorders
Weight gain
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
6.7%
2/30 • Number of events 2 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Breast pain
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/31 • from enrollment until end of follow-up, up to 13 months
|
3.3%
1/30 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
3.2%
1/31 • Number of events 1 • from enrollment until end of follow-up, up to 13 months
|
0.00%
0/30 • from enrollment until end of follow-up, up to 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place