Trial Outcomes & Findings for Optimization of Adaptive Text Messages for Cancer Survivors (OATS II) (NCT NCT05746195)
NCT ID: NCT05746195
Last Updated: 2026-01-22
Results Overview
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
COMPLETED
NA
46 participants
At 12 weeks
2026-01-22
Participant Flow
Participant milestones
| Measure |
Text Message Intervention
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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Overall Study
STARTED
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46
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Overall Study
COMPLETED
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46
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)
Baseline characteristics by cohort
| Measure |
Text Message Intervention
n=46 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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Age, Customized
30-39 years old
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2 Participants
n=270 Participants
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Age, Customized
40-49 years old
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5 Participants
n=270 Participants
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Age, Customized
50-59 years old
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12 Participants
n=270 Participants
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Age, Customized
60-69 years old
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16 Participants
n=270 Participants
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Age, Customized
70-79 years old
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8 Participants
n=270 Participants
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Age, Customized
80-89 years old
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3 Participants
n=270 Participants
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Sex: Female, Male
Female
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32 Participants
n=270 Participants
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Sex: Female, Male
Male
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14 Participants
n=270 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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6 Participants
n=270 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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39 Participants
n=270 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=270 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=270 Participants
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Race (NIH/OMB)
Asian
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4 Participants
n=270 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=270 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=270 Participants
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Race (NIH/OMB)
White
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30 Participants
n=270 Participants
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Race (NIH/OMB)
More than one race
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7 Participants
n=270 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=270 Participants
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Region of Enrollment
United States
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46 participants
n=270 Participants
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PRIMARY outcome
Timeframe: Up to 12 weeksThe percentage of text messages responded to is defined as the number of text messages with a response divided by the total number of text messages that ask for a reply and calculated on a per patient basis. The intervention will be determined feasible if the median response rate (percentage of text messages that participants responded to) across all participants is \>= 70%.
Outcome measures
| Measure |
Text Message Intervention
n=46 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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Median Percentage of Text Messages That Participants Responded to That Asked for a Reply
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96 percentage of text messages
Interval 90.0 to 98.0
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PRIMARY outcome
Timeframe: At 12 weeksPopulation: Two participants did not complete this survey at 12 weeks
The system usability is comprised of 10 questions assessing participants perceived usability of the intervention. Each item is scored on a scale of 1 (strongly disagree) to 5 ( strongly agree). The SUS yields a single number representing a composite measure of the overall usability of the text messaging system. To calculate the SUS score, Each item's score contribution will ultimately range from 0 to 4 (For items 1,3,5,7,and 9 the score contribution is the item score minus 1 and for items 2,4,6,8 and 10, the contribution is the item score minus 5). The sum of the scores are then multiplied by 2.5 to obtain the overall value. SUS scores have a range of 0 to 100 with a score \> 68 indicating above average usability.
Outcome measures
| Measure |
Text Message Intervention
n=44 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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|---|---|
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Overall Median Score on the System Usability Scale (SUS)
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72.5 score on a scale
Interval 65.0 to 85.0
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PRIMARY outcome
Timeframe: At 12 weeksPopulation: Two participants did not complete this survey at 12 weeks
The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
Outcome measures
| Measure |
Text Message Intervention
n=44 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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|---|---|
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Overall Score on the Acceptability of Intervention Measure (AIM)
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4 score on a scale
Interval 3.0 to 4.5
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PRIMARY outcome
Timeframe: At 12 weeksPopulation: Two participants did not complete this survey at 12 weeks
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
Outcome measures
| Measure |
Text Message Intervention
n=44 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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|---|---|
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Overall Score on the Intervention Appropriateness Measure (IAM)
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4 scores on a scale
Interval 3.4 to 4.9
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PRIMARY outcome
Timeframe: At 12 weeksPopulation: Two participants did not complete this survey at 12 weeks
The FIM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.
Outcome measures
| Measure |
Text Message Intervention
n=44 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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|---|---|
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Feasibility of Intervention Measure (FIM)
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4 scores on a scale
Interval 3.8 to 4.0
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SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Two participants did not complete this survey at 12 weeks
The FFQ will ask about diet in the past 3 months. For each item, participants will be asked to report how often, on average, they ate the specified portion size in the past 3 months. Participants can choose from frequency options ranging from never or less than once per month to \>=6 times a day. To compute calorie and nutrient intakes, multiply the frequency of consumption of each food by the amount of each nutrient in the specified portion size using composition values from the U.S. Department of Agriculture and other sources. Percent of grains that are whole = servings per day of whole grains/(servings per day of refined grains + servings per day of whole grains) will be reported over time
Outcome measures
| Measure |
Text Message Intervention
n=44 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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Change in Percent of Grains That Are Whole Reported on the Food Frequency Questionnaire (FFQ)
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22.1 percentage of grains consumed
Interval 13.5 to 30.7
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SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Two participants did not complete this survey at 12 weeks
The FFQ will ask about diet in the past 3 months. For each item, participants will be asked to report how often, on average, they ate the specified portion size in the past 3 months. Participants can choose from frequency options ranging from never or less than once per month to \>=6 times a day. To compute calorie and nutrient intakes, multiply the frequency of consumption of each food by the amount of each nutrient in the specified portion size using composition values from the U.S. Department of Agriculture and other sources. The mean total daily fiber intake and standard deviation will be reported over time.
Outcome measures
| Measure |
Text Message Intervention
n=44 Participants
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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|---|---|
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Change in Mean Total Daily Fiber Intake (Grams Per Day (g/d)) Reported on the Food Frequency Questionnaire (FFQ)
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4.3 grams per day
Standard Deviation 9.9
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Adverse Events
Text Message Intervention
Serious adverse events
| Measure |
Text Message Intervention
n=46 participants at risk
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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|---|---|
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Nervous system disorders
Syncope (Fainted)
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2.2%
1/46 • Number of events 1 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Other adverse events
| Measure |
Text Message Intervention
n=46 participants at risk
Adaptive 12-week text message intervention using reinforcement learning to increase whole grain and reduce refined grain intake via the HealthySMS platform. Participants will also complete semi-structured follow-up interviews and various questionnaires evaluating participants dietary habits and use of study intervention.
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Gastrointestinal disorders
Abdominal pain
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15.2%
7/46 • Number of events 7 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Bloating
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19.6%
9/46 • Number of events 9 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Constipation
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13.0%
6/46 • Number of events 6 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Diarrhea
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21.7%
10/46 • Number of events 10 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Dyspepsia
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2.2%
1/46 • Number of events 1 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Flatulence
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17.4%
8/46 • Number of events 8 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Heartburn
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8.7%
4/46 • Number of events 4 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Musculoskeletal and connective tissue disorders
Arthralgia
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26.1%
12/46 • Number of events 12 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Musculoskeletal and connective tissue disorders
Myalgia
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32.6%
15/46 • Number of events 15 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Nausea
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17.4%
8/46 • Number of events 8 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Nervous system disorders
Paresthesia
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17.4%
8/46 • Number of events 8 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Gastrointestinal disorders
Dysphagia
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2.2%
1/46 • Number of events 1 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Ear and labyrinth disorders
Tinnitus
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2.2%
1/46 • Number of events 1 • Up to 12 weeks
Pre-existing expected adverse events (e.g., diarrhea, constipation, etc.) were be assessed at enrollment and emergent events assessed at 12 weeks using a selected list of symptoms from the Patient reported outcome version of the CTCAE (PRO-CTCAE). Participants were also provided an opportunity to report additional symptoms not specifically selected in the PRO-CTCAE.
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Additional Information
Dr. Erin Van Blarigan, ScD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place