Trial Outcomes & Findings for Brief Behavioral Intervention for Insomnia During Chemotherapy (NCT NCT02165839)
NCT ID: NCT02165839
Last Updated: 2020-12-03
Results Overview
The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: * 0 to 7 = No clinically significant insomnia * 8 to14 = Sub-threshold insomnia (mild) * 15 to 21 = Clinical insomnia (moderate severity) * 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.
COMPLETED
NA
139 participants
12 months
2020-12-03
Participant Flow
Participant milestones
| Measure |
Healthy Eating Education Learning (HEAL)
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
Experimental Group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
73
|
|
Overall Study
COMPLETED
|
66
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brief Behavioral Intervention for Insomnia During Chemotherapy
Baseline characteristics by cohort
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
Total
n=139 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
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
139 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
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 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
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
73 participants
n=7 Participants
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: T2 (Post intervention): 5 participants were lost to follow up \& didn't complete any measures. T3 (6 months follow-up): 16 participants did not complete any measures \& were lost to follow up (including 2 deceased). T4 (12 months follow-up): 14 participants did not complete any measures \& were lost to follow up (including 3 deceased).
The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: * 0 to 7 = No clinically significant insomnia * 8 to14 = Sub-threshold insomnia (mild) * 15 to 21 = Clinical insomnia (moderate severity) * 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.
Outcome measures
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Insomnia Severity Index (ISI)
T1 (Baseline)
|
13.73 score on a scale
Standard Deviation 5.11
|
14.93 score on a scale
Standard Deviation 4.84
|
|
Insomnia Severity Index (ISI)
T2 (Post intervention)
|
11.28 score on a scale
Standard Deviation 5.43
|
10.16 score on a scale
Standard Deviation 4.31
|
|
Insomnia Severity Index (ISI)
T3 (6 months follow-up)
|
9.53 score on a scale
Standard Deviation 5.33
|
8.87 score on a scale
Standard Deviation 5.87
|
|
Insomnia Severity Index (ISI)
T4 (12 months follow-up)
|
9.51 score on a scale
Standard Deviation 5.35
|
8.98 score on a scale
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: T2: 5 participants were lost to follow up \& did not complete any measures. T3: 16 participants did not complete any measures \& were lost to follow up (including 2 deceased). T4: 14 participants did not complete any measures \& were lost to follow up (including 3 deceased).
The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall BFI scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Outcome measures
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Brief Fatigue Inventory (BFI)
T1 (Baseline)
|
4.44 score on a scale
Standard Deviation 2.28
|
4.02 score on a scale
Standard Deviation 2.27
|
|
Brief Fatigue Inventory (BFI)
T2 (Post intervention)
|
4.32 score on a scale
Standard Deviation 2.20
|
3.88 score on a scale
Standard Deviation 2.20
|
|
Brief Fatigue Inventory (BFI)
T3 (6 months follow-up)
|
3.27 score on a scale
Standard Deviation 2.07
|
3.00 score on a scale
Standard Deviation 2.03
|
|
Brief Fatigue Inventory (BFI)
T4 (12 months follow-up)
|
3.28 score on a scale
Standard Deviation 2.18
|
2.80 score on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: T2(Post intervention): 6 participants were lost to follow \& did not complete any measures. T3(6 months follow-up): 19 participants did not complete follow-up study visit \& were lost to follow up (including 2 deceased). T4(12 months follow-up): 17 participants did not complete follow-up study visit \& were lost to follow up (including 3 deceased).
Anxiety and depression will be assessed by administration of the Clinical Assessment of Depression (CAD). The CAD questionnaire is a 50-item survey, with each statement having 4 possible responses ("Strongly Disagree" to "Strongly Agree"), scored from 1 to 4, The raw scores are then converted to T-scores. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. The CAD survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CAD scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Outcome measures
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Clinical Assessment of Depression (CAD)
T1 (Baseline)
|
54.38 score on a scale
Standard Deviation 11.86
|
55.44 score on a scale
Standard Deviation 10.80
|
|
Clinical Assessment of Depression (CAD)
T2 (Post intervention)
|
53.14 score on a scale
Standard Deviation 11.25
|
54.32 score on a scale
Standard Deviation 11.59
|
|
Clinical Assessment of Depression (CAD)
T3 (6 months follow-up)
|
51.15 score on a scale
Standard Deviation 13.13
|
51.40 score on a scale
Standard Deviation 10.58
|
|
Clinical Assessment of Depression (CAD)
T4 (12 months follow-up)
|
49.74 score on a scale
Standard Deviation 12.58
|
50.60 score on a scale
Standard Deviation 10.66
|
SECONDARY outcome
Timeframe: At baseline, post intervention, 6 months and 12 monthsPopulation: T1(Baseline): 1 participant did not complete baseline assessment. T2(Post intervention): Total 7 participants were not analyzed; 6 participants were lost to follow up and 1 participant did not complete this measure T3(6 months follow-up): 19 participants did not complete follow-up (including 2 deceased). T4(12 months follow-up): 18 participants did not complete follow-up(including 3 deceased).
Neuropsychological assessments will be conducted using the Comprehensive Trail Making Test (CTMT), an assessment of simple attention and executive function, consisting of 5 dot-to-dot exercises that increase with complexity and difficulty. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. Overall, higher values indicate better executive functioning, attention, and processing speed. The CTMT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CTMT scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Outcome measures
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Comprehensive Trail Making Test (CTMT)
T1 (Baseline)
|
44.22 score on a scale
Standard Deviation 7.76
|
41.44 score on a scale
Standard Deviation 7.98
|
|
Comprehensive Trail Making Test (CTMT)
T2 (Post intervention)
|
48.68 score on a scale
Standard Deviation 8.79
|
45.04 score on a scale
Standard Deviation 8.68
|
|
Comprehensive Trail Making Test (CTMT)
T3 (6 months follow-up)
|
48.68 score on a scale
Standard Deviation 8.29
|
46.53 score on a scale
Standard Deviation 8.33
|
|
Comprehensive Trail Making Test (CTMT)
T4 (12 months follow-up)
|
49.26 score on a scale
Standard Deviation 7.86
|
47.92 score on a scale
Standard Deviation 7.56
|
SECONDARY outcome
Timeframe: At baseline, post intervention, 6 months and 12 monthsPopulation: T2 (Post intervention): 6 participants were lost to follow up \& did not complete any measures. T3(6 months follow-up): 18 participants did not complete follow-up study visit (including 2 deceased). T4(12 months follow-up): 17 participants did not complete follow-up study visit (including 3 deceased).
Neuropsychological assessments will be conducted using the Delayed Recall sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score. A higher T scores indicating better memory (recall).A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Delayed Recall was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Outcome measures
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall
T1 (Baseline)
|
49.05 score on a scale
Standard Deviation 10.83
|
49.42 score on a scale
Standard Deviation 9.58
|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall
T2 (Post intervention)
|
49.06 score on a scale
Standard Deviation 10.95
|
46.96 score on a scale
Standard Deviation 11.05
|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall
T3 (6 months follow-up)
|
50.70 score on a scale
Standard Deviation 9.78
|
51.68 score on a scale
Standard Deviation 9.63
|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall
T4 (12 months follow-up)
|
52.95 score on a scale
Standard Deviation 8.30
|
52.68 score on a scale
Standard Deviation 8.67
|
SECONDARY outcome
Timeframe: At baseline, post intervention, 6 months and 12 monthsPopulation: T2(Post intervention): 6 participants were lost to follow up \& did not complete any measures. T3 (6 months follow-up): 18 participants did not complete follow-up visit (including 2 deceased). T4 (12 months follow-up): 17 participants did not complete follow-up visit (including 3 deceased).
Neuropsychological assessments will be conducted using the Verbal Learning and Memory sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score.The higher T scores indicating better memory (recall). A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Verbal Learning and Memory was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Outcome measures
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory
T1 (Baseline)
|
48.94 score on a scale
Standard Deviation 11.45
|
50.23 score on a scale
Standard Deviation 11.30
|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory
T2 (Post intervention)
|
49.44 score on a scale
Standard Deviation 12.27
|
50.42 score on a scale
Standard Deviation 11.32
|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory
T3 (6 months follow-up)
|
53.21 score on a scale
Standard Deviation 10.78
|
53.85 score on a scale
Standard Deviation 9.66
|
|
Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory
T4 (12 months follow-up)
|
56.05 score on a scale
Standard Deviation 9.60
|
56.93 score on a scale
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: At baseline, post intervention, 6 months and 12 monthsPopulation: T2: 6 participants were lost to follow \& did not complete any measures. T3: 18 participants did not complete the 6-month follow-up study visit \& were lost to follow up (including 2 deceased). T4: 17 participants did not complete the 12-month follow-up study visit \& were lost to follow up (including 3 deceased).
Neuropsychological assessments will be conducted using the Controlled Oral Word Association Test (COWAT), a verbal fluency task that assesses complex cognition. The test value is the the count of words that meet pre-defined criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Adjustments are made to the raw score based on participant age and education level, resulting in a scaled score. Higher scores reflect a better outcome, meaning better cognition and verbal fluency. The COWAT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the COWAT score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Outcome measures
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 Participants
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 Participants
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Controlled Oral Word Association Test (COWAT)
T1 (Baseline)
|
41.95 score on a scale
Standard Deviation 9.87
|
39.51 score on a scale
Standard Deviation 11.97
|
|
Controlled Oral Word Association Test (COWAT)
T2 (Post intervention)
|
42.19 score on a scale
Standard Deviation 11.36
|
40.43 score on a scale
Standard Deviation 12.36
|
|
Controlled Oral Word Association Test (COWAT)
T3 (6 months follow-up)
|
45.72 score on a scale
Standard Deviation 11.11
|
43.53 score on a scale
Standard Deviation 12.06
|
|
Controlled Oral Word Association Test (COWAT)
T4 (12 months follow-up)
|
44.61 score on a scale
Standard Deviation 10.22
|
42.73 score on a scale
Standard Deviation 11.77
|
SECONDARY outcome
Timeframe: At baseline, post intervention, 6 months and 12 monthsPopulation: No analysis. The MCAB analysis was determined to not be a validated measure, and the analysis was not conducted as the scores are not standardized and results do not have meaning at this time.
Cognitive difficulties will be assessed by administration of the Mobile Cognitive Assessment Battery (MCAB), comprised of 3 neuropsychological tests and a self-reported assessment. MCAB measures cognitive flexibility, accuracy, processing speed, working memory and multitasking. The MCAB survey was to be conducted at baseline, post intervention, 6 months, and 12 months. The outcome was to be reported as the mean of the overall MCAB scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Outcome measures
Outcome data not reported
Adverse Events
Healthy Eating Education Learning (HEAL)
Brief Behavioral Therapy for Insomnia (BBT-I)
Serious adverse events
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 participants at risk
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 participants at risk
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
General disorders
Disease Progression
|
0.00%
0/66 • 52 months
|
4.1%
3/73 • Number of events 3 • 52 months
|
|
Blood and lymphatic system disorders
Blood Transfusion
|
0.00%
0/66 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms
|
0.00%
0/66 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
2/66 • Number of events 2 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Infections and infestations
Sepsis
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Infections and infestations
Shingles
|
0.00%
0/66 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
Other adverse events
| Measure |
Healthy Eating Education Learning (HEAL)
n=66 participants at risk
Control group. Healthy Eating Education Learning (HEAL)
|
Brief Behavioral Therapy for Insomnia (BBT-I)
n=73 participants at risk
Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
|
|---|---|---|
|
Vascular disorders
Hematoma
|
1.5%
1/66 • Number of events 1 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Infections and infestations
Skin infection
|
1.5%
1/66 • Number of events 1 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Cardiac disorders
Palpitations
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/66 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/66 • 52 months
|
2.7%
2/73 • Number of events 2 • 52 months
|
|
Infections and infestations
Infection: not specified
|
3.0%
2/66 • Number of events 2 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Immune system disorders
Allergic reaction
|
6.1%
4/66 • Number of events 5 • 52 months
|
0.00%
0/73 • 52 months
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
General disorders
Pain
|
3.0%
2/66 • Number of events 2 • 52 months
|
0.00%
0/73 • 52 months
|
|
General disorders
Fever
|
3.0%
2/66 • Number of events 2 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Infections and infestations
Breast infection
|
0.00%
0/66 • 52 months
|
2.7%
2/73 • Number of events 2 • 52 months
|
|
Psychiatric disorders
Depression
|
4.5%
3/66 • Number of events 3 • 52 months
|
8.2%
6/73 • Number of events 6 • 52 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
4/66 • Number of events 4 • 52 months
|
2.7%
2/73 • Number of events 2 • 52 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/66 • Number of events 1 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify:Dermatomyositis
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Cardiac disorders
Chest pain- cardiac
|
3.0%
2/66 • Number of events 2 • 52 months
|
0.00%
0/73 • 52 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders- other, specify: Crohn's
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Vascular disorders
Hypotension
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction: GI symptoms (unspecified)
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
General disorders
Localized Edema
|
0.00%
0/66 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/66 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/66 • 52 months
|
1.4%
1/73 • Number of events 1 • 52 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
|
Injury, poisoning and procedural complications
Intraoperative breast injury: Breast necrosis
|
1.5%
1/66 • Number of events 1 • 52 months
|
0.00%
0/73 • 52 months
|
Additional Information
Oxana Palesh, Associate Professor of Psychiatry and Behavioral Sciences
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place