Trial Outcomes & Findings for Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics (NCT NCT00612560)
NCT ID: NCT00612560
Last Updated: 2017-10-12
Results Overview
Mean percentage of cells expressing estrogen receptor (ER-beta)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Biopsy/Week 1 and Surgical Resection/Week 2
Results posted on
2017-10-12
Participant Flow
Participant milestones
| Measure |
Arm A - Flaxseed & Active Anastrazole
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
8
|
6
|
|
Overall Study
COMPLETED
|
7
|
7
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics
Baseline characteristics by cohort
| Measure |
Arm A - Flaxseed & Active Anastrazole
n=7 Participants
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
n=7 Participants
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
n=8 Participants
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
n=6 Participants
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
Total
n=28 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
58 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
65 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
64 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
62 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2Population: All treated and eligible patients with a large enough of a sample for analysis
Mean percentage of cells expressing estrogen receptor (ER-beta)
Outcome measures
| Measure |
Arm A - Flaxseed & Active Anastrazole
n=7 Participants
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
n=6 Participants
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
n=4 Participants
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
n=6 Participants
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
|---|---|---|---|---|
|
Expression of Estrogen Receptor (ER-beta)
Biopsy
|
67.1 percentage of cells
Standard Deviation 17.0
|
63.3 percentage of cells
Standard Deviation 10.3
|
45.0 percentage of cells
Standard Deviation 23.8
|
62.0 percentage of cells
Standard Deviation 13.0
|
|
Expression of Estrogen Receptor (ER-beta)
Surgical resection
|
45.7 percentage of cells
Standard Deviation 28.8
|
56.7 percentage of cells
Standard Deviation 23.4
|
46.7 percentage of cells
Standard Deviation 32.1
|
70 percentage of cells
Standard Deviation 30.9
|
PRIMARY outcome
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2Population: All treated and eligible patients with a large enough of a sample for analysis
Mean percentage of cells expressing PR
Outcome measures
| Measure |
Arm A - Flaxseed & Active Anastrazole
n=2 Participants
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
n=5 Participants
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
n=2 Participants
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
n=4 Participants
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
|---|---|---|---|---|
|
Progesterone Receptor (PR) Expression
Biopsy
|
4 percentage of cells
Standard Deviation 1.4
|
3.5 percentage of cells
Standard Deviation 0.7
|
2 percentage of cells
|
4.7 percentage of cells
Standard Deviation 0.5
|
|
Progesterone Receptor (PR) Expression
Surgical resection
|
4.5 percentage of cells
Standard Deviation 0.7
|
2.4 percentage of cells
Standard Deviation 1.1
|
1 percentage of cells
Standard Deviation 1.4
|
3.5 percentage of cells
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2Population: All treated and eligible patients with a large enough of a sample for analysis.
Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2)
Outcome measures
| Measure |
Arm A - Flaxseed & Active Anastrazole
n=2 Participants
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
n=4 Participants
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
n=2 Participants
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
n=2 Participants
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
|---|---|---|---|---|
|
Human Epidermal Growth Factor Receptor 2 (Her2) Expression
Biopsy
|
15 percentage of cells
Standard Deviation 7.0
|
40 percentage of cells
|
—
|
55 percentage of cells
Standard Deviation 63.6
|
|
Human Epidermal Growth Factor Receptor 2 (Her2) Expression
Surgical resection
|
0 percentage of cells
Standard Deviation 0
|
17.5 percentage of cells
Standard Deviation 16.6
|
17.5 percentage of cells
Standard Deviation 17.7
|
30 percentage of cells
|
SECONDARY outcome
Timeframe: Biopsy/Week 1 and Surgical Resection/Week 2Population: All treated and eligible patients with a large enough of a sample for analysis
Mean serum level IGF-1(pg/ml)
Outcome measures
| Measure |
Arm A - Flaxseed & Active Anastrazole
n=6 Participants
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
n=7 Participants
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
n=7 Participants
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
n=6 Participants
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
|---|---|---|---|---|
|
Growth Hormone Serum Levels IGF-1
Biopsy
|
887.7 pg/ml
Standard Deviation 654.4
|
1044.2 pg/ml
Standard Deviation 700.4
|
959.1 pg/ml
Standard Deviation 408.6
|
1008.3 pg/ml
Standard Deviation 686.7
|
|
Growth Hormone Serum Levels IGF-1
Surgical resection
|
938.1 pg/ml
Standard Deviation 652.9
|
980.5 pg/ml
Standard Deviation 743.2
|
819.8 pg/ml
Standard Deviation 334.3
|
880.1 pg/ml
Standard Deviation 698.0
|
Adverse Events
Arm A - Flaxseed & Active Anastrazole
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm B - Flaxseed
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm C - Anastrozole
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm D - Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Flaxseed & Active Anastrazole
n=7 participants at risk
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
n=7 participants at risk
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
n=8 participants at risk
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
n=6 participants at risk
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Arm A - Flaxseed & Active Anastrazole
n=7 participants at risk
25 mg flaxseed per day and 1 mg anastrozole pill per day
Anastrozole: 1 mg per day
flaxseed: 25 g per day ground
|
Arm B - Flaxseed
n=7 participants at risk
Flaxseed 25 mg per day and 1 placebo pill per day
flaxseed: 25 g per day ground
|
Arm C - Anastrozole
n=8 participants at risk
Anastrozole 1 mg pill per day
Anastrozole: 1 mg per day
|
Arm D - Placebo
n=6 participants at risk
Placebo pill 1 per day
Placebo: Placebo pill 1 per day
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/7
|
28.6%
2/7 • Number of events 10
|
0.00%
0/8
|
0.00%
0/6
|
|
Eye disorders
Vision blurred
|
0.00%
0/7
|
0.00%
0/7
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal distension
|
28.6%
2/7 • Number of events 6
|
28.6%
2/7 • Number of events 4
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Number of events 10
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Number of events 8
|
14.3%
1/7 • Number of events 2
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 2
|
28.6%
2/7 • Number of events 8
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Flatulence
|
71.4%
5/7 • Number of events 12
|
57.1%
4/7 • Number of events 14
|
0.00%
0/8
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
|
14.3%
1/7 • Number of events 6
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Asthenia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
37.5%
3/8 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Chills
|
0.00%
0/7
|
28.6%
2/7 • Number of events 10
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 6
|
0.00%
0/7
|
37.5%
3/8 • Number of events 7
|
83.3%
5/6 • Number of events 5
|
|
General disorders
Feeling abnormal
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Feeling cold
|
0.00%
0/7
|
28.6%
2/7 • Number of events 8
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Irritability
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Mastitis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7
|
14.3%
1/7 • Number of events 4
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Weight decreased
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Weight increased
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7
|
28.6%
2/7 • Number of events 6
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Number of events 4
|
14.3%
1/7 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7
|
14.3%
1/7 • Number of events 4
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Disturbance in attention
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 4
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 2
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 6
|
42.9%
3/7 • Number of events 8
|
12.5%
1/8 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
14.3%
1/7 • Number of events 2
|
28.6%
2/7 • Number of events 6
|
0.00%
0/8
|
50.0%
3/6 • Number of events 3
|
|
Nervous system disorders
Lethargy
|
14.3%
1/7 • Number of events 4
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • Number of events 2
|
28.6%
2/7 • Number of events 4
|
25.0%
2/8 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Tension headache
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Decreased interest
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Psychiatric disorders
Depressed mood
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Disturbance in sexual arousal
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 2
|
28.6%
2/7 • Number of events 4
|
25.0%
2/8 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Breast pain
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7
|
14.3%
1/7 • Number of events 6
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7
|
14.3%
1/7 • Number of events 4
|
0.00%
0/8
|
50.0%
3/6 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
42.9%
3/7 • Number of events 8
|
28.6%
2/7 • Number of events 6
|
25.0%
2/8 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 2
|
14.3%
1/7 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hot flush
|
28.6%
2/7 • Number of events 4
|
28.6%
2/7 • Number of events 4
|
37.5%
3/8 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place