Trial Outcomes & Findings for Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast (NCT NCT03063619)
NCT ID: NCT03063619
Last Updated: 2024-02-22
Results Overview
To determine change of mammographic breast density using Cumulus software. Cumulus is a semi-automated computerized measure of dense area that uses reader-based thresholds to define the breast edge and regions of density on a digital or digitized mammogram. Each pixel within the breast area between the skin line and pectoral muscle is segmented into either fat or fibro glandular tissue; this defines the cut-off point.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
194 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2024-02-22
Participant Flow
A total of 194 participants have been accrued, 158 randomized, 78 and 80 in 4-OHT gel and placebo, respectively.
Eleven participants withdrew consent, 19 ineligible, 6 other reasons (denied insurance, lost to follow-up, logistics).
Participant milestones
| Measure |
4-OHT Gel
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
80
|
|
Overall Study
Baseline
|
78
|
80
|
|
Overall Study
Month 12
|
67
|
65
|
|
Overall Study
Month 24
|
56
|
55
|
|
Overall Study
COMPLETED
|
67
|
65
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast
Baseline characteristics by cohort
| Measure |
4-OHT Gel
n=78 Participants
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
n=80 Participants
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
Total
n=158 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
|
65 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Mammographic breast density data are available in a total of 133 participants, two without baseline data, six without month-12 data and two with 12-month mammograms beyond 18 months therefore are not considered evaluable for Month 12 evaluation. Therefore, a total of 123 participants are evaluable for the primary endpoint, 61 in 4-OHT and 62 in Placebo.
To determine change of mammographic breast density using Cumulus software. Cumulus is a semi-automated computerized measure of dense area that uses reader-based thresholds to define the breast edge and regions of density on a digital or digitized mammogram. Each pixel within the breast area between the skin line and pectoral muscle is segmented into either fat or fibro glandular tissue; this defines the cut-off point.
Outcome measures
| Measure |
4-OHT Gel
n=61 Participants
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
n=62 Participants
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
|---|---|---|
|
Mammographic Breast Density Using Cumulus Software
Craniocaudal View (CC view)
|
-6.30 Percent Change in Breast Density
Standard Deviation 9.11
|
-5.77 Percent Change in Breast Density
Standard Deviation 11.24
|
|
Mammographic Breast Density Using Cumulus Software
Mediolateral Oblique View (MLO view)
|
-2.81 Percent Change in Breast Density
Standard Deviation 6.74
|
-5.43 Percent Change in Breast Density
Standard Deviation 9.08
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: A total of 59 participants have been evaluated for breast density at either baseline or month 12 or both by Volpara data, however 23 in 4-OHT and 24 in Placebo by CC view, and 25 in 4-OHT and 24 in Placebo by MLO view are evaluable for percent change in mammographic breast density.
To determine change of mammographic breast density using Volpara software. Volpara software uses a combination of x-ray physics and machine learning to generate an accurate volumetric measure of breast composition.
Outcome measures
| Measure |
4-OHT Gel
n=32 Participants
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
n=27 Participants
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
|---|---|---|
|
Mammographic Breast Density Using Volpara Software
Craniocaudal View (CC view)
|
-1.31 Percent Change in Breast Density
Standard Deviation 1.87
|
-0.85 Percent Change in Breast Density
Standard Deviation 2.35
|
|
Mammographic Breast Density Using Volpara Software
Mediolateral Oblique View (MLO view)
|
-0.92 Percent Change in Breast Density
Standard Deviation 4.26
|
-0.30 Percent Change in Breast Density
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: A total of 59 and 57 participants in 4-OHT and Placebo arms, respectively, have Month 12 measures on 4-OHT in plasma. All baseline measures are Below Qualification Limit (BQL).
To evaluate plasma measurements of 4-OHT levels, Z-4-OH-Tamoxifen.
Outcome measures
| Measure |
4-OHT Gel
n=59 Participants
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
n=57 Participants
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
|---|---|---|
|
4-OHT Plasma Levels
Below Qualification Limit (BQL) at 12 months
|
42 participants
|
57 participants
|
|
4-OHT Plasma Levels
Greater than BQL at 12 months
|
17 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: A total of 12 and 18 participants in 4-OHT and Placebo arms, respectively, have Month 12 measures on 4-OHT in tissue. All baseline measures are Below Qualification Limit (BQL).
To evaluate tissue measurements of 4-OHT levels, Z-4-OH-Tamoxifen
Outcome measures
| Measure |
4-OHT Gel
n=12 Participants
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
n=18 Participants
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
|---|---|---|
|
4-OHT Tissue Levels
Below Qualification Limit (BQL)
|
2 participants
|
18 participants
|
|
4-OHT Tissue Levels
Greater than BQL
|
10 participants
|
0 participants
|
Adverse Events
4-OHT Gel
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4-OHT Gel
n=78 participants at risk
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
n=80 participants at risk
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
|---|---|---|
|
Gastrointestinal disorders
Acute Diverticulitis
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Infections and infestations
Appendicitis
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Infections and infestations
Perianal Abscess
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Automobile Accident/Injury
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right Breast IDC/Neoplasms
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Breast Cancer/Neoplasms
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
Other adverse events
| Measure |
4-OHT Gel
n=78 participants at risk
Participants apply 4-OHT Gel topically to each breast QD for up to 52 weeks.
4-OHT Gel: Applied topically
|
Placebo
n=80 participants at risk
Participants apply Placebo gel topically to each breast QD for up to 52 weeks.
Placebo: Applied topically
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Investigations
Alanine aminotransferase increased
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Immune system disorders
Allergic reaction
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.1%
4/78 • Number of events 4 • Baseline up to Month 12
|
3.8%
3/80 • Number of events 3 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Psychiatric disorders
Anxiety
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
3.8%
3/80 • Number of events 3 • Baseline up to Month 12
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Bloating
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Eye disorders
Blurred vision
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Infections and infestations
Bronchial infection
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Bruising
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Eye disorders
Cataract
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
General disorders
Chills
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Investigations
Cholesterol high
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Eye disorders
Conjunctivitis
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
10.0%
8/80 • Number of events 8 • Baseline up to Month 12
|
|
Psychiatric disorders
Depression
|
0.00%
0/78 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
4/78 • Number of events 4 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
3.8%
3/80 • Number of events 3 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Renal and urinary disorders
Dyspareunia
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
General disorders
Edema limbs
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Entercolitis Infections
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/78 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
General disorders
Fatigue
|
6.4%
5/78 • Number of events 5 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
General disorders
Fever
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
General disorders
Flu-like symptoms
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
16.7%
13/78 • Number of events 13 • Baseline up to Month 12
|
20.0%
16/80 • Number of events 16 • Baseline up to Month 12
|
|
Nervous system disorders
Headache
|
14.1%
11/78 • Number of events 11 • Baseline up to Month 12
|
10.0%
8/80 • Number of events 8 • Baseline up to Month 12
|
|
Vascular disorders
Hot flashes
|
16.7%
13/78 • Number of events 13 • Baseline up to Month 12
|
7.5%
6/80 • Number of events 6 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Vascular disorders
Hypertension
|
3.8%
3/78 • Number of events 3 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Psychiatric disorders
Insomnia
|
5.1%
4/78 • Number of events 4 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
General disorders
Irritability
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Lip infection
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Mucosal infection
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Nail infection
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
6.2%
5/80 • Number of events 5 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Nausea
|
3.8%
3/78 • Number of events 3 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Nervous system disorders
Olfactory nerve disorder
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Otitis media
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
General disorders
Pain
|
3.8%
3/78 • Number of events 3 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
General disorders
Pain in extremity
|
3.8%
3/78 • Number of events 3 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Nervous system disorders
Paresthesia
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
3.8%
3/80 • Number of events 3 • Baseline up to Month 12
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
General disorders
Photosensitivity
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Nervous system disorders
Presyncope
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.8%
3/78 • Number of events 3 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Sinusitis
|
6.4%
5/78 • Number of events 5 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.3%
8/78 • Number of events 8 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Sore throat
|
0.00%
0/78 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Stomach pain
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
General disorders
Toothache
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Tooth Infection
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.1%
4/78 • Number of events 4 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Renal and urinary disorders
Urinary tract infection
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Uterine obstruction
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Investigations
Weight gain
|
7.7%
6/78 • Number of events 6 • Baseline up to Month 12
|
5.0%
4/80 • Number of events 4 • Baseline up to Month 12
|
|
Investigations
Weight loss
|
3.8%
3/78 • Number of events 3 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Immune system disorders
Wound Complication
|
0.00%
0/78 • Baseline up to Month 12
|
1.2%
1/80 • Number of events 1 • Baseline up to Month 12
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
0.00%
0/80 • Baseline up to Month 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
3.8%
3/80 • Number of events 3 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
1.3%
1/78 • Number of events 1 • Baseline up to Month 12
|
3.8%
3/80 • Number of events 3 • Baseline up to Month 12
|
|
Reproductive system and breast disorders
Breast Pain
|
9.0%
7/78 • Number of events 7 • Baseline up to Month 12
|
8.8%
7/80 • Number of events 7 • Baseline up to Month 12
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
2.6%
2/78 • Number of events 2 • Baseline up to Month 12
|
2.5%
2/80 • Number of events 2 • Baseline up to Month 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place