Trial Outcomes & Findings for Flushing Reduction Associated With Nitrates (NCT NCT02714205)
NCT ID: NCT02714205
Last Updated: 2025-03-28
Results Overview
Change was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
Repeated change from baseline to 5 and 12 weeks
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
Transdermal Nitroglycerin
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
|
Overall Study
COMPLETED
|
66
|
70
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Transdermal Nitroglycerin
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Overall Study
Cannot tolerate medication
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Too busy
|
1
|
0
|
|
Overall Study
Incomplete outcome data
|
0
|
1
|
Baseline Characteristics
Flushing Reduction Associated With Nitrates
Baseline characteristics by cohort
| Measure |
Transdermal Nitroglycerin
n=70 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=71 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.27 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
53.89 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
54.57 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
141 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
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
71 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
Hot Flash Frequency (per day)
|
10.77 episodes per day
STANDARD_DEVIATION 4.0 • n=5 Participants
|
10.9 episodes per day
STANDARD_DEVIATION 2.9 • n=7 Participants
|
10.84 episodes per day
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Hot Flash Related Daily Interference Scale (HFRDIS) score
|
46.11 units on a scale
STANDARD_DEVIATION 23.1 • n=5 Participants
|
40.30 units on a scale
STANDARD_DEVIATION 21.0 • n=7 Participants
|
43.18 units on a scale
STANDARD_DEVIATION 22.2 • n=5 Participants
|
|
Menopause Quality of Life (MENQOL), Vasomotor domain score
|
6.49 units on a scale
STANDARD_DEVIATION 23.1 • n=5 Participants
|
6.21 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
6.35 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI) score
|
8.03 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
7.74 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
7.88 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Generalized Anxiety Disorder-7 (GAD-7) score
|
3.13 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 3.0 • n=7 Participants
|
2.80 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Center for Epidemiologic Studies Depression (CES-D) Score
|
8.35 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 7.6 • n=7 Participants
|
8.63 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Moderate-to-severe hot flashes (per day)
|
8.68 episodes per day
STANDARD_DEVIATION 4.1 • n=5 Participants
|
8.10 episodes per day
STANDARD_DEVIATION 3.0 • n=7 Participants
|
8.39 episodes per day
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Total hot flash severity score
|
21.10 units on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
|
20.42 units on a scale
STANDARD_DEVIATION 6.0 • n=7 Participants
|
20.76 units on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points.
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=66 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=70 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline Hot Flash Frequency
|
-4.56 Hot flashes per day
Interval -6.01 to -3.11
|
-4.02 Hot flashes per day
Interval -5.41 to -2.63
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points. Range 0-100, Higher score indicates lower quality of life
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=66 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=71 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline Hot Flash Related Daily Interference Scale (HFRDIS) Score
|
-19.85 units on a scale
Interval -28.5 to -11.2
|
-20.36 units on a scale
Interval -28.61 to -12.12
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points. Range 1-8, Higher score indicates lower quality of life
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=66 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=71 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline Menopause Quality of Life (MENQOL), Vasomotor Domain Score
|
-1.53 units on a scale
Interval -2.42 to -0.64
|
-1.33 units on a scale
Interval -2.17 to -0.49
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points Range 0-21, Higher score indicates lower quality of life
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=65 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=70 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
|
-1.27 score on a scale
Interval -2.23 to -0.31
|
-1.18 score on a scale
Interval -2.1 to -0.26
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points Range 0-21, Higher score indicates lower quality of life
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=66 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=71 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline Generalized Anxiety Disorder-7 (GAD-7) Score
|
-0.15 units on a scale
Interval -1.18 to 0.89
|
-0.57 units on a scale
Interval -1.56 to 0.42
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points Range 0-60, a higher score indicates a lower quality of life.
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=65 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=70 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline Center for Epidemiologic Studies Depression (CES-D) Score
|
-1.39 units on a scale
Interval -3.89 to 1.11
|
-1.79 units on a scale
Interval -4.18 to 0.6
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=66 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=70 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change in Baseline Frequency of Moderate-to-severe Hot Flashes
|
-3.27 Hot flashes per day
Interval -4.64 to -1.9
|
-2.44 Hot flashes per day
Interval -3.74 to -1.14
|
SECONDARY outcome
Timeframe: Repeated change from baseline to 5 and 12 weeksChange was calculated as the followup value minus the baseline value. Values are model generated Least Square Means for combined 5 and 12 month time points. The hot flash severity score is calculated as the sum of severity ratings for all hot flashes recorded on the symptom over a 7-day period (mild=1, moderate=2, severe=3), and then divided by 7 for the daily average score. Range 12-60, higher score indicates lower quality of life.
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=66 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=70 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Change in Baseline Total Hot Flash Severity Score
|
-8.33 units on a scale
Interval -11.44 to -5.21
|
-6.92 units on a scale
Interval -9.89 to -3.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 weeksNumber of participants with treatment related severe adverse events defined by Common Terminology Criteria for Adverse Events (CTCAE) severity grade 3 or higher.
Outcome measures
| Measure |
Transdermal Nitroglycerin
n=66 Participants
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=71 Participants
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Number of Participants With Treatment Related Severe Adverse Events Defined by Common Terminology Criteria for Adverse Events (CTCAE) Severity Grade 3 or Higher.
|
0 Participants
|
0 Participants
|
Adverse Events
Transdermal Nitroglycerin
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transdermal Nitroglycerin
n=70 participants at risk
Daily transdermal nitroglycerin patch, starting at 0.2 mg/hr. Dose escalation up to 0.6 mg/hr.
transdermal nitroglycerin: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
Placebo
n=71 participants at risk
Daily transdermal placebo patch.
Placebo: Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Heart Fluttering
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
Palpitations
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.3%
3/70 • Number of events 6 • 16 weeks
|
5.6%
4/71 • Number of events 5 • 16 weeks
|
|
Gastrointestinal disorders
Soft Stools
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Gastrointestinal disorders
Sore Tongue
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Stomach Discomfort
|
1.4%
1/70 • Number of events 2 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Upset Stomach
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 2 • 16 weeks
|
|
General disorders
Chest Pain
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
General disorders
Chest Pain Aggravated
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
General disorders
Chest Pressure Sensation
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
General disorders
Fatigue
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
General disorders
Feelings Of Weakness
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Infections and infestations
Breast Cellulitis
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Infections and infestations
Coronavirus Infection
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Stomach Flu
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
7/70 • Number of events 7 • 16 weeks
|
11.3%
8/71 • Number of events 9 • 16 weeks
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Ankle Sprain
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Coccyx Injury
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Meniscus Tear
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Mosquito Bite
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Injury, poisoning and procedural complications
Thigh Strain
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Arm Discomfort
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Ache
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Hand Pain
|
2.9%
2/70 • Number of events 2 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Discomfort
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis Aggravated
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal Carcinoma In Situ
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
7.1%
5/70 • Number of events 6 • 16 weeks
|
9.9%
7/71 • Number of events 9 • 16 weeks
|
|
Nervous system disorders
Headache
|
82.9%
58/70 • Number of events 95 • 16 weeks
|
85.9%
61/71 • Number of events 101 • 16 weeks
|
|
Nervous system disorders
Lost Consciousness
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Nervous system disorders
Numbness Of Upper Extremities
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Taste Abnormality
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Psychiatric disorders
Agitation
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Psychiatric disorders
Depression Nos
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Psychiatric disorders
Emotional Distress
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/70 • 16 weeks
|
2.8%
2/71 • Number of events 2 • 16 weeks
|
|
Reproductive system and breast disorders
Dyspareunia; Vaginal Bleeding
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pressure
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Erythematous Skin Rash
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Localised Rash
|
11.4%
8/70 • Number of events 9 • 16 weeks
|
23.9%
17/71 • Number of events 19 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Poison Oak Rash
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritic Rash
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
2.9%
2/70 • Number of events 2 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Erythema
|
1.4%
1/70 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
|
Vascular disorders
Raynaud-Like Phenomena
|
0.00%
0/70 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
Additional Information
Mike Schembri, Data Systems Analyst
University of California, San Francisco
Phone: 415-353-7161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place