Trial Outcomes & Findings for Telephone Support for Metastatic Breast Cancer Patients (NCT NCT03998618)
NCT ID: NCT03998618
Last Updated: 2024-10-10
Results Overview
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
250 participants
Primary outcome timeframe
2 weeks, 3 months, and 6 months post-intervention
Results posted on
2024-10-10
Participant Flow
14 patients were excluded from the study before assignment to groups. Here is a list of the reasons: Not feeling well/health problems (2), Did not have time (5), Participation was too much work (4), Not interested in the study (1), Not eligible (1), Other (1)
Participant milestones
| Measure |
Acceptance and Commitment Therapy
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
120
|
|
Overall Study
COMPLETED
|
97
|
91
|
|
Overall Study
NOT COMPLETED
|
19
|
29
|
Reasons for withdrawal
| Measure |
Acceptance and Commitment Therapy
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
|---|---|---|
|
Overall Study
Death
|
7
|
11
|
|
Overall Study
hospice enrollment
|
3
|
3
|
|
Overall Study
Not feeling well/health problems
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
Telephone Support for Metastatic Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Acceptance and Commitment Therapy
n=116 Participants
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
n=120 Participants
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
58.97 years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
236 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
116 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Household income
$0 to $50,999
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Household income
$51,000 to $99,999
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Household income
$100,000 or more
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Household income
Missing data
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Years of education
|
15.3 years
STANDARD_DEVIATION 2.38 • n=5 Participants
|
15.2 years
STANDARD_DEVIATION 2.73 • n=7 Participants
|
15.27 years
STANDARD_DEVIATION 2.56 • n=5 Participants
|
|
Time since stage IV breast cancer diagnosis
|
2.75 years
STANDARD_DEVIATION 3.62 • n=5 Participants
|
2.94 years
STANDARD_DEVIATION 3.72 • n=7 Participants
|
2.85 years
STANDARD_DEVIATION 3.67 • n=5 Participants
|
|
Chemotherapy
Yes-chemotherapy received for breast cancer
|
85 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Chemotherapy
No-chemotherapy not received for breast cancer
|
31 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Radiation
Yes-radiation received for breast cancer
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Radiation
No-radiation not received for breast cancer
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Hormonal Therapy
Yes-hormonal therapy received for breast cancer
|
90 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Hormonal Therapy
No-hormonal therapy not received for breast cancer
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Targeted Therapy
Yes-targeted therapy received for breast cancer
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Targeted Therapy
No-targeted therapy not received for breast cancer
|
79 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 3 months, and 6 months post-interventionSeven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=116 Participants
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
n=120 Participants
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
|---|---|---|
|
Fatigue Interference Subscale of Fatigue Symptom Inventory
Fatigue interference at 2 weeks post-intervention
|
2.96 units on a scale
Standard Deviation 1.90
|
3.66 units on a scale
Standard Deviation 2.20
|
|
Fatigue Interference Subscale of Fatigue Symptom Inventory
Fatigue interference at 3 months post-intervention
|
3.24 units on a scale
Standard Deviation 2.05
|
3.43 units on a scale
Standard Deviation 2.25
|
|
Fatigue Interference Subscale of Fatigue Symptom Inventory
Fatigue interference at 6 months post-intervention
|
3.08 units on a scale
Standard Deviation 2.32
|
3.64 units on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: 2 weeks, 3 months, and 6 months post-interventionThis 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=116 Participants
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
n=120 Participants
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment
Sleep-related impairment at 2 weeks post-intervention
|
55.28 T-score
Standard Deviation 4.22
|
56.26 T-score
Standard Deviation 4.27
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment
Sleep-related impairment at 3 months post-intervention
|
54.27 T-score
Standard Deviation 7.79
|
54.62 T-score
Standard Deviation 8.91
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment
Sleep-related impairment at 6 months post-intervention
|
54.05 T-score
Standard Deviation 7.95
|
54.78 T-score
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: 2 weeks, 3 months, and 6 months post-interventionThis 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=116 Participants
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
n=120 Participants
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
|---|---|---|
|
PROMIS Ability to Participate in Social Roles and Activities
Ability to participate in social roles and activities at 2 weeks post-intervention
|
46.75 T-score
Standard Deviation 6.79
|
46.66 T-score
Standard Deviation 6.86
|
|
PROMIS Ability to Participate in Social Roles and Activities
Ability to participate in social roles and activities at 3 months post-intervention
|
47.49 T-score
Standard Deviation 7.91
|
46.75 T-score
Standard Deviation 8.56
|
|
PROMIS Ability to Participate in Social Roles and Activities
Ability to participate in social roles and activities at 6 months post-intervention
|
46.81 T-score
Standard Deviation 8.17
|
46.10 T-score
Standard Deviation 8.01
|
SECONDARY outcome
Timeframe: 2 weeks, 3 months, and 6 months post-interventionThis 27-item measure evaluates physical, social/family, emotional, and functional quality of life. For each of the 4 subscale scores (i.e., Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being), the items are summed, multiplied by the number of items, and divided by the number of items answered, with higher scores indicating better quality of life. Items are rated on 0 to 4 scales. The physical well-being subscale is the sum of 7 items (all items reverse-coded) with a range of 0 to 28. The social/family well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. The emotional well-being subscale is the sum of 6 items (5 items reverse-coded) with a range of 0 to 24. The functional well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. This is a secondary outcome measure.
Outcome measures
| Measure |
Acceptance and Commitment Therapy
n=116 Participants
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
n=120 Participants
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
|---|---|---|
|
Functional Assessment of Cancer Therapy-General
Physical quality of life at 2 weeks post-intervention
|
17.73 units on a scale
Standard Deviation 5.06
|
16.99 units on a scale
Standard Deviation 5.08
|
|
Functional Assessment of Cancer Therapy-General
Physical quality of life at 3 months post-intervention
|
17.34 units on a scale
Standard Deviation 5.80
|
16.90 units on a scale
Standard Deviation 6.07
|
|
Functional Assessment of Cancer Therapy-General
Physical quality of life at 6 months post-intervention
|
17.18 units on a scale
Standard Deviation 6.05
|
16.54 units on a scale
Standard Deviation 6.15
|
|
Functional Assessment of Cancer Therapy-General
Social/family quality of life at 2 weeks post-intervention
|
21.15 units on a scale
Standard Deviation 4.71
|
20.58 units on a scale
Standard Deviation 5.47
|
|
Functional Assessment of Cancer Therapy-General
Social/family quality of life at 3 months post-intervention
|
20.39 units on a scale
Standard Deviation 5.38
|
20.71 units on a scale
Standard Deviation 5.49
|
|
Functional Assessment of Cancer Therapy-General
Social/family quality of life at 6 months post-intervention
|
20.36 units on a scale
Standard Deviation 5.05
|
20.72 units on a scale
Standard Deviation 6.34
|
|
Functional Assessment of Cancer Therapy-General
Emotional quality of life at 2 weeks post-intervention
|
16.72 units on a scale
Standard Deviation 4.20
|
16.24 units on a scale
Standard Deviation 4.81
|
|
Functional Assessment of Cancer Therapy-General
Emotional quality of life at 3 months post-intervention
|
16.42 units on a scale
Standard Deviation 4.53
|
16.16 units on a scale
Standard Deviation 4.92
|
|
Functional Assessment of Cancer Therapy-General
Emotional quality of life at 6 months post-intervention
|
16.21 units on a scale
Standard Deviation 4.84
|
16.79 units on a scale
Standard Deviation 5.01
|
|
Functional Assessment of Cancer Therapy-General
Functional quality of life at 2 weeks post-intervention
|
17.84 units on a scale
Standard Deviation 4.53
|
16.99 units on a scale
Standard Deviation 5.39
|
|
Functional Assessment of Cancer Therapy-General
Functional quality of life at 3 months post-intervention
|
17.18 units on a scale
Standard Deviation 4.90
|
16.85 units on a scale
Standard Deviation 5.36
|
|
Functional Assessment of Cancer Therapy-General
Functional quality of life at 6 months post-intervention
|
17.47 units on a scale
Standard Deviation 5.43
|
16.68 units on a scale
Standard Deviation 5.28
|
Adverse Events
Acceptance and Commitment Therapy
Serious events: 7 serious events
Other events: 0 other events
Deaths: 7 deaths
Education/Support
Serious events: 11 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Acceptance and Commitment Therapy
n=116 participants at risk
Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
|
Education/Support
n=120 participants at risk
Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
|
|---|---|---|
|
General disorders
Deaths
|
6.0%
7/116 • Number of events 7 • Adverse event data were collected on each participant from the point of baseline until approximately 8 months post-baseline.
|
9.2%
11/120 • Number of events 11 • Adverse event data were collected on each participant from the point of baseline until approximately 8 months post-baseline.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place