Trial Outcomes & Findings for Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers (NCT NCT03109847)
NCT ID: NCT03109847
Last Updated: 2025-12-11
Results Overview
Will be modeled using mixed effects linear regression
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 36 months of study duration
Results posted on
2025-12-11
Participant Flow
Participant milestones
| Measure |
Arm I (metformin hydrochloride)
Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.
Metformin Hydrochloride: Given Orally
Radioactive Iodine: Undergo radioactive iodine treatment
|
Arm II (placebo)
Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment
Radioactive Iodine: Undergo radioactive iodine treatment
Placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm I (metformin hydrochloride)
Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.
Metformin Hydrochloride: Given Orally
Radioactive Iodine: Undergo radioactive iodine treatment
|
Arm II (placebo)
Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment
Radioactive Iodine: Undergo radioactive iodine treatment
Placebo: Given orally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers
Baseline characteristics by cohort
| Measure |
Arm II (Placebo)
n=7 Participants
Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment
Radioactive Iodine: Undergo radioactive iodine treatment
Placebo: Given orally
|
Arm I (Metformin Hydrochloride)
n=5 Participants
Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.
Metformin Hydrochloride: Given Orally
Radioactive Iodine: Undergo radioactive iodine treatment
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=480 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=243 Participants
|
4 Participants
n=237 Participants
|
9 Participants
n=480 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=243 Participants
|
1 Participants
n=237 Participants
|
3 Participants
n=480 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=243 Participants
|
4 Participants
n=237 Participants
|
7 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=243 Participants
|
1 Participants
n=237 Participants
|
5 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=243 Participants
|
1 Participants
n=237 Participants
|
1 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=243 Participants
|
4 Participants
n=237 Participants
|
11 Participants
n=480 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
1 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=243 Participants
|
5 Participants
n=237 Participants
|
11 Participants
n=480 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=243 Participants
|
0 Participants
n=237 Participants
|
0 Participants
n=480 Participants
|
PRIMARY outcome
Timeframe: Up to 36 months of study duration, an average of 1.5 monthsPopulation: Participants with both pre- and post-treatment CBC values were included in the analysis. Due to missing laboratory data, 4 participants in Arm 1 (Metformin) and 3 participants in Arm 2 (Placebo) were analyzable for this outcome.
Change in red blood cell count measured from baseline to two weeks after completion of RAI, measured via standard CBC laboratory testing. Longitudinal measures of CBC will be modeled using mixed effects linear regression. Will use a linear contrast to test the null hypothesis that change from pre-resection to post-resection is the same in the control and metformin groups.
Outcome measures
| Measure |
Arm I (metformin hydrochloride)
n=4 Participants
Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.
Metformin Hydrochloride: Given Orally
Radioactive Iodine: Undergo radioactive iodine treatment
|
Arm II (placebo)
n=3 Participants
Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment
Radioactive Iodine: Undergo radioactive iodine treatment
Placebo: Given orally
|
|---|---|---|
|
Change in Red Blood Cell Count From Pre-Resection to Post-Resection
|
-0.11 million cells per microliter
Interval -0.74 to 0.51
|
-0.63 million cells per microliter
Interval -2.7 to 1.45
|
PRIMARY outcome
Timeframe: Up to 36 months of study durationPopulation: The study terminated early due to poor accrual; no samples collected for exosome profiling. Therefore, no participants were analyzed for this outcome. Data were not collected and the outcome cannot be reported.
Will be modeled using mixed effects linear regression
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 36 months of study duration, an average of 1.5 monthsNumber of adverse events assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version v 4.0, from treatment initiation through 15 days post-treatment follow-up.
Outcome measures
| Measure |
Arm I (metformin hydrochloride)
n=5 Participants
Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.
Metformin Hydrochloride: Given Orally
Radioactive Iodine: Undergo radioactive iodine treatment
|
Arm II (placebo)
n=6 Participants
Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment
Radioactive Iodine: Undergo radioactive iodine treatment
Placebo: Given orally
|
|---|---|---|
|
Number of Adverse Events
|
32 Adverse Events
|
11 Adverse Events
|
SECONDARY outcome
Timeframe: Up to 36 months of study durationPopulation: The study terminated early due to poor accrual; no surveys collected for Xerostomia. Therefore, no participants were analyzed for this outcome. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 months of study durationPopulation: The study terminated early due to poor accrual; no surveys collected for Xerophthalmia. Therefore, no participants were analyzed for this outcome. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 months of study durationPopulation: The study terminated early due to poor accrual; no surveys collected for Dysgeusia. Therefore, no participants were analyzed for this outcome. Data were not collected due to study termination prior to participants' assessment at the pre-specified time points
Outcome measures
Outcome data not reported
Adverse Events
Arm I (metformin hydrochloride)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm II (placebo)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (metformin hydrochloride)
n=6 participants at risk
Patients receive metformin hydrochloride PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment.
Metformin Hydrochloride: Given Orally
Radioactive Iodine: Undergo radioactive iodine treatment
|
Arm II (placebo)
n=7 participants at risk
Patients receive placebo PO daily for 3 days and then PO BID for up to 2 weeks after completing radioactive iodine treatment
Radioactive Iodine: Undergo radioactive iodine treatment
Placebo: Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Eye disorders
Blurry Vision - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
50.0%
3/6 • Number of events 4 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Diarrhea - Grade 2
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Diarrhea - Grade 3
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Nervous system disorders
Dysgeusia - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Nervous system disorders
Dysgeusia - Grade 2
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Ear and labyrinth disorders
Ear Pain - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
General disorders
Face Edema - Grade 1
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
General disorders
Fatigue - Grade 1
|
16.7%
1/6 • Number of events 2 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Nervous system disorders
Headache - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Knee & Achilles Pain - grade 1
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
66.7%
4/6 • Number of events 5 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
50.0%
3/6 • Number of events 4 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain - Grade 1
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
28.6%
2/7 • Number of events 2 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Upset stomach - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
33.3%
2/6 • Number of events 2 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Vomiting - Grade 3
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Dysphagia - Grade 1
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Jaw Pain - Grade 2
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Nervous system disorders
Numbness - Grade 1
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat - Grade 1
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Vascular disorders
superficial thrombophlebitis - Grade 2
|
0.00%
0/6 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
14.3%
1/7 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Musculoskeletal and connective tissue disorders
Weakness - Grade 1
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
|
Gastrointestinal disorders
Xerostomia - Grade 2
|
16.7%
1/6 • Number of events 1 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
0.00%
0/7 • The study period during which adverse events must be reported is normally defined as the period from the initiation of any study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up is defined as 15 days following the last administration of study treatment, an average of 1.5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place