Trial Outcomes & Findings for A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy (NCT NCT02569801)
NCT ID: NCT02569801
Last Updated: 2021-04-23
Results Overview
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Results posted on
2021-04-23
Participant Flow
Participant milestones
| Measure |
GDC-0810
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
|
Overall Study
Received Treatment
|
35
|
35
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
35
|
Reasons for withdrawal
| Measure |
GDC-0810
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
9
|
|
Overall Study
Sponsor Decision
|
13
|
14
|
|
Overall Study
Progressive Disease
|
2
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
12
|
4
|
Baseline Characteristics
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Baseline characteristics by cohort
| Measure |
GDC-0810
n=36 Participants
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
n=35 Participants
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)Population: Outcome Measures not assessed based on pre-specified thresholds not having been met.
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)Population: Outcome Measures not assessed based on pre-specified thresholds not having been met.
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)Population: Outcome Measures not assessed based on pre-specified thresholds not having been met.
OS is defined as the time from randomization to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)Objective Response was defined as the percentage of participants who attained CR or PR. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
GDC-0810
n=36 Participants
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
n=35 Participants
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1
|
0 percentage
Interval 0.0 to 0.0
|
8.6 percentage
Interval 3.19 to 19.28
|
SECONDARY outcome
Timeframe: From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months)Population: Outcome Measures not assessed based on pre-specified thresholds not having been met.
DOR was defined as the time from first observation of an objective response until first observation of disease progression as assessed by the investigator according to RECIST v1.1 or death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)Outcome measures
| Measure |
GDC-0810
n=36 Participants
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
n=35 Participants
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1
|
16.7 percentage of participants
Interval 7.52 to 30.22
|
31.4 percentage of participants
Interval 19.28 to 44.84
|
SECONDARY outcome
Timeframe: From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months)Population: Participants who received at least one dose of any study drug
Outcome measures
| Measure |
GDC-0810
n=35 Participants
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
n=35 Participants
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
AEs
|
97.1 percentage of participants
|
91.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
SAEs
|
20.0 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 daysPopulation: Participants who received at least one dose of any study drug and provided a post-dose blood sample in the GDC-0810 arm
Concentration of GDC-0810 measured in plasma after a single dose (Cycle 1 Day 1) and at steady state (Cycle 3 Day 1)
Outcome measures
| Measure |
GDC-0810
n=32 Participants
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
GDC-0810 Plasma Concentrations by Visit
Cycle 1, Day 1 (3 hours post-dose)
|
6510 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 574
|
—
|
|
GDC-0810 Plasma Concentrations by Visit
Cycle 3, Day 1 (pre-dose)
|
528 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 266
|
—
|
|
GDC-0810 Plasma Concentrations by Visit
Cycle 3, Day 1 (3 hours post-dose)
|
10100 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 132
|
—
|
Adverse Events
GDC-0810
Serious events: 7 serious events
Other events: 33 other events
Deaths: 12 deaths
Fulvestrant
Serious events: 5 serious events
Other events: 31 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
GDC-0810
n=35 participants at risk
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
n=35 participants at risk
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.00%
0/35 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Gastrointestinal disorders
GASTRITIS HAEMORRHAGIC
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Gastrointestinal disorders
NAUSEA
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/35 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/35 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/35 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Nervous system disorders
BRACHIAL PLEXOPATHY
|
0.00%
0/35 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Vascular disorders
LYMPHOEDEMA
|
0.00%
0/35 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
Other adverse events
| Measure |
GDC-0810
n=35 participants at risk
Participants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
Fulvestrant
n=35 participants at risk
Participants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.6%
3/35 • Number of events 4 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Cardiac disorders
PALPITATIONS
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.9%
8/35 • Number of events 8 • Up to approximately 25 months
|
17.1%
6/35 • Number of events 7 • Up to approximately 25 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
42.9%
15/35 • Number of events 24 • Up to approximately 25 months
|
22.9%
8/35 • Number of events 10 • Up to approximately 25 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
11.4%
4/35 • Number of events 4 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Gastrointestinal disorders
NAUSEA
|
31.4%
11/35 • Number of events 12 • Up to approximately 25 months
|
14.3%
5/35 • Number of events 7 • Up to approximately 25 months
|
|
Gastrointestinal disorders
VOMITING
|
28.6%
10/35 • Number of events 14 • Up to approximately 25 months
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
|
General disorders
ASTHENIA
|
22.9%
8/35 • Number of events 10 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
General disorders
FATIGUE
|
20.0%
7/35 • Number of events 7 • Up to approximately 25 months
|
28.6%
10/35 • Number of events 10 • Up to approximately 25 months
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/35 • Up to approximately 25 months
|
11.4%
4/35 • Number of events 5 • Up to approximately 25 months
|
|
Infections and infestations
PNEUMONIA
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
11.4%
4/35 • Number of events 4 • Up to approximately 25 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 3 • Up to approximately 25 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Investigations
WEIGHT DECREASED
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
17.1%
6/35 • Number of events 7 • Up to approximately 25 months
|
17.1%
6/35 • Number of events 7 • Up to approximately 25 months
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
8.6%
3/35 • Number of events 4 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
8.6%
3/35 • Number of events 4 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.6%
3/35 • Number of events 5 • Up to approximately 25 months
|
20.0%
7/35 • Number of events 7 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/35 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/35 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/35 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Nervous system disorders
DIZZINESS
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Nervous system disorders
DYSGEUSIA
|
11.4%
4/35 • Number of events 4 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Nervous system disorders
HEADACHE
|
2.9%
1/35 • Number of events 2 • Up to approximately 25 months
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/35 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Psychiatric disorders
INSOMNIA
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
11.4%
4/35 • Number of events 4 • Up to approximately 25 months
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/35 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Reproductive system and breast disorders
BREAST PAIN
|
5.7%
2/35 • Number of events 3 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
17.1%
6/35 • Number of events 7 • Up to approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.6%
3/35 • Number of events 3 • Up to approximately 25 months
|
11.4%
4/35 • Number of events 4 • Up to approximately 25 months
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/35 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
2.9%
1/35 • Number of events 1 • Up to approximately 25 months
|
17.1%
6/35 • Number of events 6 • Up to approximately 25 months
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/35 • Up to approximately 25 months
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
|
Vascular disorders
HYPERTENSION
|
5.7%
2/35 • Number of events 2 • Up to approximately 25 months
|
0.00%
0/35 • Up to approximately 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER