Trial Outcomes & Findings for Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients (NCT NCT01434342)
NCT ID: NCT01434342
Last Updated: 2021-09-28
Results Overview
The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
146 participants
Primary outcome timeframe
24 Weeks
Results posted on
2021-09-28
Participant Flow
Participants are recruited from NCI CCOP sites
Participant milestones
| Measure |
Quitline
Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.
Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 we
|
Usual Care
Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
48
|
|
Overall Study
COMPLETED
|
50
|
31
|
|
Overall Study
NOT COMPLETED
|
48
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
Baseline characteristics by cohort
| Measure |
Arm I - Quitline
n=98 Participants
Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.
Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 we
|
Arm II
n=48 Participants
Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
|
Total
n=146 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
|
69 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
58 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
117 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
|
98 participants
n=5 Participants
|
48 participants
n=7 Participants
|
146 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: All randomized participants
The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.
Outcome measures
| Measure |
Arm I - Quitline
n=98 Participants
Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.
The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.
Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.
Participants also learn behavioral tips and coping skills.
|
Arm II - Usual Care
n=48 Participants
Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
|
|---|---|---|
|
Feasibility of a Smoking Cessation Intervention Among Cancer Patients
|
55 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All randomized participants
Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm
Outcome measures
| Measure |
Arm I - Quitline
n=98 Participants
Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.
The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.
Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.
Participants also learn behavioral tips and coping skills.
|
Arm II - Usual Care
Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
|
|---|---|---|
|
Adherence
|
81 Participants
|
—
|
Adverse Events
Arm I - Quitline
Serious events: 14 serious events
Other events: 61 other events
Deaths: 0 deaths
Arm II - Usual Care
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Quitline
n=75 participants at risk
Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.
Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 we
|
Arm II - Usual Care
n=37 participants at risk
Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
3/75 • Number of events 3 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Infections and infestations
Bladder Infection
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/75 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
2.7%
1/37 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Gastrointestinal disorders
Dry Mouth
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
3/75 • Number of events 3 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
5.4%
2/37 • Number of events 2 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
General disorders
Fatigue
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/75 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
2.7%
1/37 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Nervous system disorders
Headache
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Psychiatric disorders
Insomnia
|
2.7%
2/75 • Number of events 2 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
2.7%
1/37 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Infections and infestations
Lung Infection
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Infections and infestations
Mucosal Infection
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Gastrointestinal disorders
Mucositis Oral
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
1.3%
1/75 • Number of events 2 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Blood and lymphatic system disorders
Neutrophil Count
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
General disorders
Pain
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Nervous system disorders
Seizure
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Infections and infestations
Wound infection
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
Other adverse events
| Measure |
Arm I - Quitline
n=75 participants at risk
Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.
Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, \& 24 we
|
Arm II - Usual Care
n=37 participants at risk
Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
|
|---|---|---|
|
Nervous system disorders
Nervous system disorder
|
1.3%
1/75 • Number of events 2 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
5.4%
2/37 • Number of events 2 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
General disorders
Pain
|
16.0%
12/75 • Number of events 16 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
10.8%
4/37 • Number of events 9 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
4/75 • Number of events 4 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
8.1%
3/37 • Number of events 6 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.7%
17/75 • Number of events 17 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
10.8%
4/37 • Number of events 4 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Psychiatric disorders
Psychiatric disorder
|
5.3%
4/75 • Number of events 9 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
8.1%
3/37 • Number of events 5 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Skin and subcutaneous tissue disorders
Rash masculo-papular
|
9.3%
7/75 • Number of events 8 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
5.4%
2/37 • Number of events 2 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue
|
10.7%
8/75 • Number of events 8 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
5.4%
2/37 • Number of events 3 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
1.3%
1/75 • Number of events 1 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
5.4%
2/37 • Number of events 2 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Psychiatric disorders
Anorexia
|
4.0%
3/75 • Number of events 5 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
5.4%
2/37 • Number of events 3 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Psychiatric disorders
Anxiety
|
46.7%
35/75 • Number of events 74 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
40.5%
15/37 • Number of events 27 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Cardiac disorders
Chest pain cardiac
|
8.0%
6/75 • Number of events 9 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
8.1%
3/37 • Number of events 4 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Gastrointestinal disorders
Constipation
|
28.0%
21/75 • Number of events 41 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
24.3%
9/37 • Number of events 16 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
10/75 • Number of events 15 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
13.5%
5/37 • Number of events 9 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Psychiatric disorders
Depression
|
34.7%
26/75 • Number of events 56 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
37.8%
14/37 • Number of events 27 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
9/75 • Number of events 18 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
8.1%
3/37 • Number of events 3 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Skin and subcutaneous tissue disorders
Dry Mouth
|
28.0%
21/75 • Number of events 34 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
24.3%
9/37 • Number of events 17 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
15/75 • Number of events 30 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
18.9%
7/37 • Number of events 10 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
52.0%
39/75 • Number of events 93 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
40.5%
15/37 • Number of events 27 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Metabolism and nutrition disorders
Fatigue
|
24.0%
18/75 • Number of events 30 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
18.9%
7/37 • Number of events 14 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Nervous system disorders
Headache
|
33.3%
25/75 • Number of events 41 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
16.2%
6/37 • Number of events 8 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
General disorders
Insomnia
|
37.3%
28/75 • Number of events 58 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
29.7%
11/37 • Number of events 19 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
5.3%
4/75 • Number of events 8 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
0.00%
0/37 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Musculoskeletal and connective tissue disorders
Myalagia
|
29.3%
22/75 • Number of events 48 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
35.1%
13/37 • Number of events 28 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
|
Gastrointestinal disorders
Nausea
|
30.7%
23/75 • Number of events 41 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
8.1%
3/37 • Number of events 5 • 24 weeks
Sample size is the number of participants with follow-up toxicity data
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place