Trial Outcomes & Findings for Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias (NCT NCT04754399)
NCT ID: NCT04754399
Last Updated: 2025-05-09
Results Overview
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Baseline, week 15
Results posted on
2025-05-09
Participant Flow
1 subject was enrolled but deemed ineligible before starting treatment
Participant milestones
| Measure |
Cannabidiol (CBD)
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Cannabidiol (CBD)
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Cannabidiol (CBD) for Treatment of Aromatase Inhibitor-Associated Arthralgias
Baseline characteristics by cohort
| Measure |
Cannabidiol (CBD)
n=39 Participants
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 15Population: 11 patients missing data
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, absolute change for only one BPI item will be assessed, "joint pain and stiffness at its worst in the last week".
Outcome measures
| Measure |
Cannabidiol (CBD)
n=28 Participants
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Absolute Change in Brief Pain Inventory (BPI) Worst Pain From Baseline to Week 15
|
-2.4 units on a scale
Interval -3.22 to -1.49
|
SECONDARY outcome
Timeframe: Baseline, week 15Population: 11 patients missing data
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness at its worst in the last week", will be assessed.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=28 Participants
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Number of Patients With at Least a 2-point Reduction in BPI Worst Pain From Baseline to Week 15
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 15Population: 11 patients missing data
The BPI is a patient self-rating scale that assesses joint pain and stiffness on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). For the purpose of this measure, change from baseline to week 15 for only one BPI item, "joint pain and stiffness on the average", will be assessed.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=28 Participants
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Number of Patients With at Least a 2-point Reduction in BPI Average Pain From Baseline to Week 15
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 15Population: 11 patients missing data
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 (PROPr) is a validated questionnaire to assess patient-reported symptoms over the past 7 days in 7 PROMIS domains on a scale of 1 (worst) to 5 (best). Raw scores for each domain are calculated and then converted to a T-score, with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured: for fatigue, sleep disturbance, depression, and anxiety, higher scores represent worse symptoms; for physical functioning, ability to participate in social roles and activities, and cognitive function-abilities, higher scores mean better function.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=28 Participants
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Pain interference
|
-6.5 score on a scale
Standard Deviation 7.2
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Pain intensity
|
-1.9 score on a scale
Standard Deviation 2.1
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Cognitive function
|
2.0 score on a scale
Standard Deviation 1.2
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Depression
|
-1.7 score on a scale
Standard Deviation 4.5
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Ability to participate in social roles/activities
|
5.7 score on a scale
Standard Deviation 8.0
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Anxiety
|
-3.4 score on a scale
Standard Deviation 6.0
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Physical function
|
3.9 score on a scale
Standard Deviation 5.3
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Fatigue
|
-3.3 score on a scale
Standard Deviation 6.9
|
|
Change in Symptoms From Baseline, as Measured by the PROMIS-29+2 Profile v2.1
Sleep disturbance
|
-3.7 score on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: End of study (15 weeks)Treatment related adverse events include those that are determined to be possibly, probably or definitely related to the study drug. Number of events will be reported by dose level and grade, per Common Terminology Criteria for Adverse Events (CTCAE) v.5.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=39 Participants
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Number of Treatment Related Adverse Events
Agitation- grade 2- 25mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Nausea- grade 1- 25mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Flushing- grade 1- 25mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Anxiety- grade 1- 50mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Rash- grade 2- 50mg BID dose
|
2 number of events
|
|
Number of Treatment Related Adverse Events
Nausea- grade 1- 50mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Depression- grade 1- 75 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Stomach Pain- grade 1- 75 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Fatigue- grade 1- 75 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Headache- grade 1- 75 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Hyponatremia- grade 1- 75 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Hyperglycemia- grade 1- 75 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Peripheral motor neuropathy- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Peripheral motor neuropathy- grade 2- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Fatigue- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Memory impairment- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Anorexia- grade 2- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Diarrhea- grade 2- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Nausea- grade 1 - 100 mg BID dose
|
2 number of events
|
|
Number of Treatment Related Adverse Events
alanine aminotransferase increased- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Oral Pain- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Gastroesophageal reflux disease- grade1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Increased creatinine- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
stomach pain- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
dizziness- grade 1- 100 mg BID dose
|
1 number of events
|
|
Number of Treatment Related Adverse Events
Headache- grade 1- 100 mg BID dose
|
1 number of events
|
SECONDARY outcome
Timeframe: Baseline and week 15Population: All enrolled patients would be analyzed; however, 3 samples are missing for baseline and 9 for week 15
The number of participants with undetectable levels of estradiol circulating in blood plasma will be reported at baseline and 15 weeks.
Outcome measures
| Measure |
Cannabidiol (CBD)
n=36 Participants
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
week 2: 50 mg twice daily, approximately 12 hours apart, with food
week 3: 75 mg twice daily, approximately 12 hours apart, with food
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|
|
Number of Participants With Undetectable Levels of Estradiol
Baseline
|
8 Participants
|
|
Number of Participants With Undetectable Levels of Estradiol
15 Weeks
|
4 Participants
|
Adverse Events
Cannabidiol (CBD)- Week 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
CBD- Week 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CBD- Week 3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CBD- Week 4
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cannabidiol (CBD)- Week 1
n=39 participants at risk
Oral solution given 2x daily.
Cannabidiol (CBD): week 1: 25 mg twice daily, approximately 12 hours apart, with food
|
CBD- Week 2
n=39 participants at risk
Oral solution given 2x daily.
Cannabidiol (CBD):
week 2: 50 mg twice daily, approximately 12 hours apart, with food
|
CBD- Week 3
n=39 participants at risk
Oral solution given 2x daily.
Cannabidiol (CBD):
week 3: 75 mg twice daily, approximately 12 hours apart, with food
|
CBD- Week 4
n=39 participants at risk
Oral solution given 2x daily.
Cannabidiol (CBD):
week 4+: 100 mg twice daily, approximately 12 hours apart, with food
|
|---|---|---|---|---|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Blood bilirubin increased
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Creatinine increased
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Fatigue
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Vascular disorders
Flushing
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
5.1%
2/39 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
5.1%
2/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.1%
2/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Stomach pain
|
2.6%
1/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
0.00%
0/39 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
2.6%
1/39 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place