Trial Outcomes & Findings for Colchicine for the Treatment of Osteoarthritis of the Knee (NCT NCT03913442)

NCT ID: NCT03913442

Last Updated: 2025-02-03

Results Overview

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: Baseline, 3 Months
• Results posted on: 2025-02-03

Participant Flow

Participant milestones

Measure	Placebo Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Overall Study STARTED	60	60
Overall Study COMPLETED	51	49
Overall Study NOT COMPLETED	9	11

Reasons for withdrawal

Measure	Placebo Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Overall Study Adverse Event	0	3
Overall Study Withdrawal by Subject	5	5
Overall Study Terminations	2	1
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Colchicine for the Treatment of Osteoarthritis of the Knee

Baseline characteristics by cohort

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)	Total n=100 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 10.3 • n=5 Participants	66.1 years STANDARD_DEVIATION 10 • n=7 Participants	66.5 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	49 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 Months

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Visual Analog Scale (VAS) Pain Score	-1.45 score on a scale Standard Deviation 2.45	-1.16 score on a scale Standard Deviation 2.22

SECONDARY outcome

Timeframe: Baseline, 3 Months

The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The KOOS Pain Score refers to a specific subscale within the KOOS questionnaire that measures the severity of knee pain experienced by a patient, consisting of nine questions where each response is scored on a scale from 0 (no pain) to 4 (extreme pain), with a higher score indicating greater pain intensity; the overall pain score is then calculated as a percentage of the maximum possible score, where 0 represents the worst possible pain and 100 represents no pain at all.

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score	9.5 score on a scale Standard Deviation 20	5.2 score on a scale Standard Deviation 19

SECONDARY outcome

Timeframe: Baseline, 3 Months

The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). Each item on the KOOS is scored on a scale from 0 (no problems) to 4 (extreme problems), and then the scores are calculated to generate a final score between 0 and 100. The KOOS stiffness score is a percentage from 0 to 100 that measures how much stiffness a patient experiences in their knee. A score of 0 indicates the most stiffness, while a score of 100 indicates no stiffness.

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in the KOOS Stiffness Score	6.6 score on a scale Standard Deviation 15.7	5.5 score on a scale Standard Deviation 19.1

SECONDARY outcome

Timeframe: Baseline, 3 Months

The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Physical Function items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems. The scores for each dimension are then transformed to a scale from 0 to 100, where 0 represents extreme problems with knee function and 100 indicates no problems at all.

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in the KOOS Physical Function Score	9.8 score on a scale Standard Deviation 17.6	7.4 score on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: Baseline, 3 Months

The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). A KOOS Quality of Life score ranges from 0 to 100, where 0 represents the worst possible knee-related quality of life and 100 indicates no problems at all. A higher score indicates better quality of life related to the knee.

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in the KOOS Quality of Life Score	6.9 score on a scale Standard Deviation 22	3.5 score on a scale Standard Deviation 15.8

SECONDARY outcome

Timeframe: Baseline, 3 Months

The KOOS's five patient-relevant dimensions are scored separately: Pain (9 items); Symptoms/Stiffness (7 items); Function, Daily Living (17 items); Function, Sports and Recreational Activities (5 items); Quality of Life (4 items). The KOOS Sports and Recreational Activities 9 items are scored on a Likert scale from 0 to 4, with 0 indicating no problems and 4 indicating extreme problems relating to sports and recreational activities. The scores are then transformed to a scale from 0 to 100, with 100 indicating no knee problems with sports and recreational activities and 0 indicating extreme knee problems with sports and recreational activities .

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in the KOOS Sports and Recreational Activities	0.0 score on a scale Standard Deviation 25.8	2.8 score on a scale Standard Deviation 19.4

SECONDARY outcome

Timeframe: Baseline, 3 Months

The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms/stiffness (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in the KOOS Total Score	6.5 score on a scale Standard Deviation 20.7	4.9 score on a scale Standard Deviation 18.1

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Number of Participants Who Used Acetaminophen or Other Medications for Pain	15 Participants	13 Participants

SECONDARY outcome

Timeframe: 3 Months

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Number of Participants Who Used Acetaminophen or Other Medications for Pain	16 Participants	12 Participants

SECONDARY outcome

Timeframe: 6 weeks, 3 months

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Number of Participants Who Used Acetaminophen or Other Medications for Pain	-1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, 3 months

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Inflammatory Plasma Marker: Interleukin-1 Receptor Antagonist (IL-1Ra)	-66 pg/mL Standard Deviation 231.9	-7.3 pg/mL Standard Deviation 194

SECONDARY outcome

Timeframe: Baseline, 3 months

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Inflammatory Plasma Marker: Prostaglandin E2 (PGE2)	100 pg/mL Standard Deviation 586.4	72.4 pg/mL Standard Deviation 737.3

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: In lieu of synovitis whose measurements proved difficult, the team relied on MSK-US-measured effusions. Only 28 and 19 participants effusion data were collected for the placebo and colchicine group, respectively.

Size of effusion is measured as millimeters

Outcome measures

Measure	Placebo n=28 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=19 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Musculoskeletal Ultrasound (MSK-US)-Measured Effusion	-1.2 millimeter Standard Deviation 2.4	-1.5 millimeter Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline, 3 months

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Rates of Crystal Deposition (Urate, Calcium) on MSK-US	0 mg/dL Standard Deviation 0	0 mg/dL Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline, 3 months

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Inflammatory Plasma Marker: Highly Sensitive C-reactive Protein (hsCRP)	0.1 mg/L Standard Deviation 4.1	-4.7 mg/L Standard Deviation 15.6

SECONDARY outcome

Timeframe: Baseline, 3 months

Outcome measures

Measure	Placebo n=51 Participants Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 Participants 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Change in Inflammatory Plasma Marker: Uric Acid	0.2 mg/dL Standard Deviation 0.7	-0.8 mg/dL Standard Deviation 1.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Colchicine

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=51 participants at risk Placebo in capsule identical to study drug Placebo oral capsule: Placebo 0.8 mg or 0.6 mg orally once daily for 3 months	Colchicine n=49 participants at risk 0.6 or 0.8 mg orally once daily. Because recent studies suggest that a dose of 0.6mg may be sufficient for chronic inflammatory suppression and may reduce the already low risk of toxicity of 0.8mg, for the remainder (second half) of the study the dosage will be switched from 0.8mg to a 0.6mg dose to allow comparison of the two doses. Colchicine 0.8 mg or 0.6 mg orally once daily: Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
Gastrointestinal disorders Loose stools	21.6% 11/51 • 3 months	38.8% 19/49 • 3 months
Gastrointestinal disorders Abdominal discomfort	13.7% 7/51 • 3 months	4.1% 2/49 • 3 months
Gastrointestinal disorders Nausea/ Vomiting	9.8% 5/51 • 3 months	8.2% 4/49 • 3 months
General disorders Headache	11.8% 6/51 • 3 months	20.4% 10/49 • 3 months
Musculoskeletal and connective tissue disorders Myalgia	9.8% 5/51 • 3 months	2.0% 1/49 • 3 months

Additional Information

Michael H Pillinger, MD, FACP

NYU Langone Health

Phone: 646-501-2722

Email: Michael.Pillinger@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place