Trial Outcomes & Findings for Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066 (NCT NCT03198767)
NCT ID: NCT03198767
Last Updated: 2021-01-05
Results Overview
Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
24 hours on Day 3 of each treatment period
Results posted on
2021-01-05
Participant Flow
A total of 116 subjects were screened and 54 subjects were enrolled and randomized, with 48 completing the study. 6 subjects in Part A were discontinued due to a protocol deviation after day 3 dosing (the protein drink provided to subjects was incorrect and included 8% carbohydrate).
Participant milestones
| Measure |
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
|
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
|
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
|
Part A: LIK066 + P1: 8% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
|
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
6
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
0
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
|
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
|
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
|
Part A: LIK066 + P1: 8% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
|
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
Baseline Characteristics
Safety Analysis Set
Baseline characteristics by cohort
| Measure |
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
n=8 Participants
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
|
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
n=8 Participants
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
|
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
n=8 Participants
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
|
Part A: LIK066 + P1: 8% CHO
n=6 Participants
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
|
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
n=8 Participants
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
n=8 Participants
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
n=8 Participants
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.1 Years
n=5 Participants • Safety Analysis Set
|
45.5 Years
n=7 Participants • Safety Analysis Set
|
43.9 Years
n=5 Participants • Safety Analysis Set
|
53.3 Years
n=4 Participants • Safety Analysis Set
|
43.8 Years
n=21 Participants • Safety Analysis Set
|
50.1 Years
n=10 Participants • Safety Analysis Set
|
43.3 Years
n=115 Participants • Safety Analysis Set
|
44.3 Years
n=24 Participants • Safety Analysis Set
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants • Safety Analysis Set
|
2 Participants
n=7 Participants • Safety Analysis Set
|
2 Participants
n=5 Participants • Safety Analysis Set
|
1 Participants
n=4 Participants • Safety Analysis Set
|
0 Participants
n=21 Participants • Safety Analysis Set
|
3 Participants
n=10 Participants • Safety Analysis Set
|
4 Participants
n=115 Participants • Safety Analysis Set
|
17 Participants
n=24 Participants • Safety Analysis Set
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants • Safety Analysis Set
|
6 Participants
n=7 Participants • Safety Analysis Set
|
6 Participants
n=5 Participants • Safety Analysis Set
|
5 Participants
n=4 Participants • Safety Analysis Set
|
8 Participants
n=21 Participants • Safety Analysis Set
|
5 Participants
n=10 Participants • Safety Analysis Set
|
4 Participants
n=115 Participants • Safety Analysis Set
|
37 Participants
n=24 Participants • Safety Analysis Set
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants • Safety Analysis Set
|
1 Participants
n=7 Participants • Safety Analysis Set
|
1 Participants
n=5 Participants • Safety Analysis Set
|
0 Participants
n=4 Participants • Safety Analysis Set
|
2 Participants
n=21 Participants • Safety Analysis Set
|
1 Participants
n=10 Participants • Safety Analysis Set
|
0 Participants
n=115 Participants • Safety Analysis Set
|
8 Participants
n=24 Participants • Safety Analysis Set
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants • Safety Analysis Set
|
7 Participants
n=7 Participants • Safety Analysis Set
|
7 Participants
n=5 Participants • Safety Analysis Set
|
6 Participants
n=4 Participants • Safety Analysis Set
|
6 Participants
n=21 Participants • Safety Analysis Set
|
7 Participants
n=10 Participants • Safety Analysis Set
|
8 Participants
n=115 Participants • Safety Analysis Set
|
46 Participants
n=24 Participants • Safety Analysis Set
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Safety Analysis Set
|
0 Participants
n=7 Participants • Safety Analysis Set
|
0 Participants
n=5 Participants • Safety Analysis Set
|
0 Participants
n=4 Participants • Safety Analysis Set
|
0 Participants
n=21 Participants • Safety Analysis Set
|
0 Participants
n=10 Participants • Safety Analysis Set
|
0 Participants
n=115 Participants • Safety Analysis Set
|
0 Participants
n=24 Participants • Safety Analysis Set
|
PRIMARY outcome
Timeframe: 24 hours on Day 3 of each treatment periodPopulation: PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data.
Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.
Outcome measures
| Measure |
Part A: LIK066 + 50% CHO
n=24 Participants
Part A: LIK066 + 50% carbohydrate CHO
|
Part A: LIK066 + 25% CHO
n=24 Participants
Part A: LIK066 + 25% carbohydrate CHO
|
Part A: LIK066 + 0% CHO
n=24 Participants
Part A: LIK066 + 0% carbohydrate CHO
|
Part B: LIK066 + 50% CHO + NS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + PS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
Part B: LIK066 + 50% CHO CC
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
|---|---|---|---|---|---|---|
|
Number of Episodes of Diarrhea (Part A and Part B)
|
1.67 Number of stools
Standard Deviation 1.74
|
1.25 Number of stools
Standard Deviation 1.42
|
0.38 Number of stools
Standard Deviation 0.71
|
1.88 Number of stools
Standard Deviation 1.51
|
1.46 Number of stools
Standard Deviation 1.41
|
1.46 Number of stools
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: Day 1 to 3 of each treatment periodPopulation: PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data.
Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on days 1 to 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.
Outcome measures
| Measure |
Part A: LIK066 + 50% CHO
n=24 Participants
Part A: LIK066 + 50% carbohydrate CHO
|
Part A: LIK066 + 25% CHO
n=24 Participants
Part A: LIK066 + 25% carbohydrate CHO
|
Part A: LIK066 + 0% CHO
n=24 Participants
Part A: LIK066 + 0% carbohydrate CHO
|
Part B: LIK066 + 50% CHO + NS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + PS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
Part B: LIK066 + 50% CHO CC
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
|---|---|---|---|---|---|---|
|
Three-day Total Number of Episodes of Diarrhea (Part A and Part B)
|
3.96 Number of stools
Standard Deviation 3.01
|
2.83 Number of stools
Standard Deviation 2.97
|
1.50 Number of stools
Standard Deviation 2.02
|
4.42 Number of stools
Standard Deviation 3.41
|
3.46 Number of stools
Standard Deviation 3.24
|
4.00 Number of stools
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: 24 hours on Day 3 of each treatment periodPopulation: PD Analysis Set.
BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).
Outcome measures
| Measure |
Part A: LIK066 + 50% CHO
n=24 Participants
Part A: LIK066 + 50% carbohydrate CHO
|
Part A: LIK066 + 25% CHO
n=24 Participants
Part A: LIK066 + 25% carbohydrate CHO
|
Part A: LIK066 + 0% CHO
n=24 Participants
Part A: LIK066 + 0% carbohydrate CHO
|
Part B: LIK066 + 50% CHO + NS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + PS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
Part B: LIK066 + 50% CHO CC
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
|---|---|---|---|---|---|---|
|
Average Consistency With Bristol Stool Chart (Part A and Part B)
|
5.45 score
Standard Deviation 1.24
|
5.42 score
Standard Deviation 1.42
|
4.71 score
Standard Deviation 1.45
|
5.81 score
Standard Deviation 1.07
|
5.52 score
Standard Deviation 0.99
|
5.62 score
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 24 hours on Day 3 of each treatment periodPopulation: PD Analysis Set
Average PH of Stool at day 3
Outcome measures
| Measure |
Part A: LIK066 + 50% CHO
n=24 Participants
Part A: LIK066 + 50% carbohydrate CHO
|
Part A: LIK066 + 25% CHO
n=24 Participants
Part A: LIK066 + 25% carbohydrate CHO
|
Part A: LIK066 + 0% CHO
n=24 Participants
Part A: LIK066 + 0% carbohydrate CHO
|
Part B: LIK066 + 50% CHO + NS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + PS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
Part B: LIK066 + 50% CHO CC
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
|---|---|---|---|---|---|---|
|
Average Stool pH (Part A and Part B)
|
6.35 pH
Standard Deviation 0.44
|
6.50 pH
Standard Deviation 0.59
|
6.29 pH
Standard Deviation 0.23
|
6.52 pH
Standard Deviation 0.59
|
6.79 pH
Standard Deviation 0.67
|
6.66 pH
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: 24 hours on Day 3 of each treatment periodPopulation: PD Analysis Set
24 hour average stool weight on day 3
Outcome measures
| Measure |
Part A: LIK066 + 50% CHO
n=24 Participants
Part A: LIK066 + 50% carbohydrate CHO
|
Part A: LIK066 + 25% CHO
n=24 Participants
Part A: LIK066 + 25% carbohydrate CHO
|
Part A: LIK066 + 0% CHO
n=24 Participants
Part A: LIK066 + 0% carbohydrate CHO
|
Part B: LIK066 + 50% CHO + NS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + PS
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
Part B: LIK066 + 50% CHO CC
n=24 Participants
Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
|---|---|---|---|---|---|---|
|
Average Stool Weight (Part A and Part B)
|
136.5 gram
Standard Deviation 88.99
|
154.5 gram
Standard Deviation 87.11
|
116.7 gram
Standard Deviation 65.57
|
145.5 gram
Standard Deviation 75.21
|
177.1 gram
Standard Deviation 138.1
|
164.3 gram
Standard Deviation 108.5
|
Adverse Events
Part A: LIK066 + 50% CHO
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Part A: LIK066 + 25% CHO
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part A: LIK066 + 0% CHO
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part A: LIK066 + 8% CHO
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: LIK066 + 50% CHO + NS
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Part B: LIK066 + 50% CHO + PS
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part B: LIK066 + 50% CHO CC
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: LIK066 + 50% CHO
n=24 participants at risk
Part A: LIK066 + 50% carbohydrate CHO
|
Part A: LIK066 + 25% CHO
n=24 participants at risk
Part A: LIK066 + 25% carbohydrate CHO
|
Part A: LIK066 + 0% CHO
n=24 participants at risk
Part A: LIK066 + 0% carbohydrate CHO
|
Part A: LIK066 + 8% CHO
n=6 participants at risk
Part A: LIK066 + 8% carbohydrate CHO
|
Part B: LIK066 + 50% CHO + NS
n=24 participants at risk
Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
|
Part B: LIK066 + 50% CHO + PS
n=24 participants at risk
Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
|
Part B: LIK066 + 50% CHO CC
n=24 participants at risk
Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
20/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
70.8%
17/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
58.3%
14/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
50.0%
3/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
83.3%
20/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
70.8%
17/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
91.7%
22/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
12.5%
3/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
8.3%
2/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
8.3%
2/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
6/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
20.8%
5/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
16.7%
1/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
8.3%
2/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
33.3%
2/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
8.3%
2/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
8.3%
2/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
16.7%
4/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
12.5%
3/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
General disorders
Peripheral swelling
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
8.3%
2/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
12.5%
3/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
8.3%
2/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/6 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
0.00%
0/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
4.2%
1/24 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately22 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER