Trial Outcomes & Findings for Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH) (NCT NCT03938246)
NCT ID: NCT03938246
Last Updated: 2024-12-19
Results Overview
As determined by MRI-PDFF
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
TVB-2640 25 mg (US)
TVB-2640 tablet orally every day for 12 weeks
|
TVB-2640 50 mg (US)
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (US)
Placebo tablet orally every day for 12 weeks
|
TVB-2640 50 mg (China)
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (China)
Placebo tablet orally every day for 12 weeks
|
TVB-2640 75 mg (US)
TVB-2640 tablet orally every day for 12 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
35
|
31
|
21
|
9
|
13
|
|
Overall Study
COMPLETED
|
27
|
30
|
31
|
20
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
TVB-2640 25 mg (US)
n=33 Participants
TVB-2640 tablet orally every day for 12 weeks
|
TVB-2640 50 mg (US)
n=35 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (US)
n=31 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 50 mg (China)
n=21 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (China)
n=9 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 75 mg (US)
n=13 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
122 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
85 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
84 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
35 participants
n=7 Participants
|
31 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
13 participants
n=8 Participants
|
112 participants
n=8 Participants
|
|
Region of Enrollment
China
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
21 participants
n=4 Participants
|
9 participants
n=21 Participants
|
0 participants
n=8 Participants
|
30 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analyses using only subjects in the mITT Population who had data at Baseline and Week 12 for observed relative change values from Baseline to Week 12
As determined by MRI-PDFF
Outcome measures
| Measure |
TVB-2640 25 mg (US)
n=26 Participants
TVB-2640 tablet orally every day for 12 weeks
|
TVB-2640 50 mg (US)
n=27 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (US)
n=23 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 50 mg (China)
n=19 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (China)
n=7 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 75 mg (US)
n=7 Participants
TVB-2640 tablet orally every day for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percent Change in Hepatic Fat Fraction by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) From Baseline
|
-11.31 percent change from baseline
Standard Deviation 29.837
|
-27.59 percent change from baseline
Standard Deviation 28.354
|
2.52 percent change from baseline
Standard Deviation 33.030
|
-28.68 percent change from baseline
Standard Deviation 22.265
|
-15.63 percent change from baseline
Standard Deviation 30.789
|
-35.77 percent change from baseline
Standard Deviation 23.736
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analyses using only subjects in the mITT Population who had data at Baseline and Week 12 for observed relative change values from Baseline to Week 12
As determined by MRI-PDFF
Outcome measures
| Measure |
TVB-2640 25 mg (US)
n=26 Participants
TVB-2640 tablet orally every day for 12 weeks
|
TVB-2640 50 mg (US)
n=27 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (US)
n=23 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 50 mg (China)
n=19 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (China)
n=7 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 75 mg (US)
n=7 Participants
TVB-2640 tablet orally every day for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least a 30% Reduction in Liver Fat at Week 12.
|
7 Participants
|
16 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
TVB-2640 25 mg (US)
n=30 Participants
TVB-2640 tablet orally every day for 12 weeks
|
TVB-2640 50 mg (US)
n=31 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (US)
n=29 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 50 mg (China)
n=20 Participants
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (China)
n=9 Participants
Placebo tablet orally every day for 12 weeks
|
TVB-2640 75 mg (US)
n=7 Participants
TVB-2640 tablet orally every day for 12 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Change From Baseline in Alanine Aminotransferase (ALT)
|
-2.98 percentage of change
Standard Deviation 38.443
|
-20.46 percentage of change
Standard Deviation 25.935
|
6.82 percentage of change
Standard Deviation 37.258
|
-28.29 percentage of change
Standard Deviation 34.495
|
14.06 percentage of change
Standard Deviation 79.621
|
-3.296 percentage of change
Standard Deviation 42.5397
|
Adverse Events
TVB-2640 25 mg (US)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
TVB-2640 50 mg (US)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo (US)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
TVB-2640 50 mg (China)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo (China)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TVB-2640 75 mg (US)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TVB-2640 25 mg (US)
n=33 participants at risk
TVB-2640 tablet orally every day for 12 weeks
|
TVB-2640 50 mg (US)
n=35 participants at risk
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (US)
n=31 participants at risk
Placebo tablet orally every day for 12 weeks
|
TVB-2640 50 mg (China)
n=21 participants at risk
TVB-2640 tablet orally every day for 12 weeks
|
Placebo (China)
n=9 participants at risk
Placebo tablet orally every day for 12 weeks
|
TVB-2640 75 mg (US)
n=13 participants at risk
TVB-2640 tablet orally every day for 12 weeks
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
12.1%
4/33 • Number of events 4 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
5.7%
2/35 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
6.5%
2/31 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
15.4%
2/13 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
General disorders
Oedema peripheral
|
9.1%
3/33 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
2.9%
1/35 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
3/33 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
2.9%
1/35 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
2/33 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
5.7%
2/35 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
14.3%
3/21 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
11.1%
1/9 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Infections and infestations
Bronchitis
|
9.1%
3/33 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
3/33 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
5.7%
2/35 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
6.5%
2/31 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
9.5%
2/21 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
2/33 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
2.9%
1/35 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
4.8%
1/21 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Eye disorders
Dry Eye
|
3.0%
1/33 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
2.9%
1/35 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
38.1%
8/21 • Number of events 8 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
22.2%
2/9 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
38.5%
5/13 • Number of events 5 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Eye disorders
Asthenopia
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
11.1%
1/9 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Eye disorders
Conjunctival deposit
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
11.1%
1/9 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
11.1%
1/9 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
33.3%
7/21 • Number of events 7 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
14.3%
3/21 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
23.1%
3/13 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
2.9%
1/35 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
9.5%
2/21 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Infections and infestations
Conjunctivitis
|
3.0%
1/33 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
4.8%
1/21 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
11.1%
1/9 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
9.5%
2/21 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
11.1%
1/9 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
General disorders
Chills
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
23.1%
3/13 • Number of events 3 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
4.8%
1/21 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
1/33 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
2/33 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
15.4%
2/13 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
2.9%
1/35 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
15.4%
2/13 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
7.7%
1/13 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
4.8%
1/21 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
General disorders
Peripheral swelling
|
6.1%
2/33 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/35 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/31 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/33 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
5.7%
2/35 • Number of events 2 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
3.2%
1/31 • Number of events 1 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/21 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/9 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
0.00%
0/13 • 12 weeks
The intensity of each AE was assessed by the Investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place