Trial Outcomes & Findings for A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis (NCT NCT02883452)
NCT ID: NCT02883452
Last Updated: 2020-06-09
Results Overview
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
181 participants
Primary outcome timeframe
Week 22, 24, 26 and 28
Results posted on
2020-06-09
Participant Flow
For Part 1, participants were screened from 21 study centers in 9 countries and were enrolled from 20 study centers in 9 countries. For Part 2, participants were screened from 62 study centers in 16 countries and were enrolled from 50 study centers in 15 countries.
For Part 1, a total of 55 CD patients were screened, 45 patients were enrolled (10 screening failures) and 44 patients were randomized. For Part 2, a total of 195 CD and UC patients were screened, 136 patients were enrolled (59 screening failures) and 131 patients were randomized.
Participant milestones
| Measure |
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
|
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
12
|
8
|
66
|
65
|
|
Overall Study
COMPLETED
|
8
|
9
|
7
|
6
|
55
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
5
|
2
|
11
|
15
|
Reasons for withdrawal
| Measure |
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
|
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
0
|
2
|
5
|
|
Overall Study
Disease progression
|
1
|
0
|
0
|
1
|
4
|
5
|
|
Overall Study
Adverse Event
|
2
|
1
|
1
|
1
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
4
|
1
|
|
Overall Study
Death
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
n=13 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=11 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
n=12 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
n=8 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
Arm 1: CT-P13 SC 120/240 mg (Part 2)
n=66 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
|
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
n=65 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg), and further doses with CT-P13 SC were given up to Week 54.
|
Total
n=175 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
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
159 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Age, Continuous
|
34.0 years
n=5 Participants
|
33.0 years
n=7 Participants
|
38.5 years
n=5 Participants
|
42.0 years
n=4 Participants
|
33.0 years
n=21 Participants
|
36.0 years
n=10 Participants
|
36.0 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
80 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
95 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
157 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Region of Enrollment
Croatia
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Region of Enrollment
Czechia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Region of Enrollment
Estonia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
0 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
4 participants
n=10 Participants
|
9 participants
n=115 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=10 Participants
|
10 participants
n=115 Participants
|
|
Region of Enrollment
Latvia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
6 participants
n=10 Participants
|
8 participants
n=115 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
20 participants
n=21 Participants
|
23 participants
n=10 Participants
|
43 participants
n=115 Participants
|
|
Region of Enrollment
Portugal
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Region of Enrollment
Russia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
15 participants
n=21 Participants
|
8 participants
n=10 Participants
|
23 participants
n=115 Participants
|
|
Region of Enrollment
Slovakia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=10 Participants
|
5 participants
n=115 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=10 Participants
|
5 participants
n=115 Participants
|
|
Region of Enrollment
Ukraine
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
Region of Enrollment
Bulgaria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Week 22, 24, 26 and 28Population: The PK population consisted of the all-randomized population who received at least one full dose of study drug at Week 6 or thereafter and who had at least one PK concentration result after Week 6 treatment. Among them, patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) were included for primary PK analysis.
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=11 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=9 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
n=11 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
n=4 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 22
|
20825679.963 hr*ng/mL
Standard Deviation 8432154.3963
|
7821587.111 hr*ng/mL
Standard Deviation 3104412.5348
|
12609504.125 hr*ng/mL
Standard Deviation 5112454.7748
|
9377712.620 hr*ng/mL
|
|
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 24
|
—
|
7409271.434 hr*ng/mL
Standard Deviation 2062318.5332
|
6736990.881 hr*ng/mL
Standard Deviation 6632584.6372
|
14777046.642 hr*ng/mL
Standard Deviation 6894029.2838
|
|
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 26
|
—
|
8731448.964 hr*ng/mL
Standard Deviation 1799009.3658
|
11649915.371 hr*ng/mL
Standard Deviation 6140258.9463
|
9721425.240 hr*ng/mL
|
|
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Week 28
|
—
|
6589313.495 hr*ng/mL
Standard Deviation 984927.8419
|
7038910.791 hr*ng/mL
Standard Deviation 6502356.3807
|
14110560.823 hr*ng/mL
Standard Deviation 5628122.2174
|
PRIMARY outcome
Timeframe: Week 22Population: The PK Population consisted of all-randomized population who received at least one full dose of study drug at Week 6 or thereafter, and who had at least one PK result after Week 6 treatment. The primary PK endpoint was analyzed in patients who received all doses (full) of study drug up to Week 22 (prior to Week 22) in the PK population.
For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=59 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=57 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
|
20.9844 μg/mL
Interval 15.2173 to 28.9372
|
1.8181 μg/mL
Interval 1.3054 to 2.5324
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 54Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of CDAI score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components multiplied by the relevant weight factor; number of liquid or very soft stools (x2), abdominal pain (x5), general well-being (x7), CD complications (x20), taking lomotil/opiates for diarrhea (x30), abdominal mass (x10), deviation of hematocrit (x6), and percentage deviation from standard weight (x1). Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=28 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=25 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Baseline
|
296.38 scores on a scale
Standard Deviation 59.212
|
294.75 scores on a scale
Standard Deviation 59.899
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Week 2
|
194.89 scores on a scale
Standard Deviation 74.943
|
191.03 scores on a scale
Standard Deviation 79.250
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Week 6
|
164.99 scores on a scale
Standard Deviation 96.360
|
144.94 scores on a scale
Standard Deviation 80.123
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Week 14
|
136.29 scores on a scale
Standard Deviation 85.918
|
131.47 scores on a scale
Standard Deviation 71.444
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Week 22
|
106.55 scores on a scale
Standard Deviation 80.461
|
105.08 scores on a scale
Standard Deviation 60.970
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Week 30
|
103.81 scores on a scale
Standard Deviation 88.435
|
106.44 scores on a scale
Standard Deviation 67.705
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Week 54
|
92.03 scores on a scale
Standard Deviation 77.622
|
79.05 scores on a scale
Standard Deviation 58.960
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 54Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to CDAI-100 criteria up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. Responder according to CDAI-100 criteria was defined as a decrease in CDAI score of 100 points or more from the baseline value.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=28 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=25 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
Week 2
|
13 Participants
|
9 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
Week 6
|
16 Participants
|
17 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
Week 14
|
19 Participants
|
18 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
Week 22
|
21 Participants
|
20 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
Week 30
|
19 Participants
|
16 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
Week 54
|
18 Participants
|
16 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 54Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. The partial Mayo scores range from 0-9 with higher scores indicating increased severity of disease. The index is sum of the 3 subscores, each which range from 0 to 3; stool frequency, rectal bleeding and physician's global assessment. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=38 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=39 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Baseline
|
5.4 scores on a scale
Standard Deviation 1.31
|
5.9 scores on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Week 2
|
3.3 scores on a scale
Standard Deviation 2.18
|
3.3 scores on a scale
Standard Deviation 1.82
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Week 6
|
2.6 scores on a scale
Standard Deviation 2.13
|
2.5 scores on a scale
Standard Deviation 1.74
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Week 14
|
1.7 scores on a scale
Standard Deviation 1.62
|
2.3 scores on a scale
Standard Deviation 1.92
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Week 22
|
1.3 scores on a scale
Standard Deviation 1.63
|
2.3 scores on a scale
Standard Deviation 1.97
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Week 30
|
1.2 scores on a scale
Standard Deviation 1.59
|
1.9 scores on a scale
Standard Deviation 1.88
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Week 54
|
0.9 scores on a scale
Standard Deviation 1.31
|
1.0 scores on a scale
Standard Deviation 1.60
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 54Population: The efficacy population consisted of the all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC or CT-P13 IV) at Week 6 or thereafter and who had at least 1 efficacy evaluation result after Week 6 treatment. All patients in the efficacy population were analyzed according to the treatment they received.
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to the partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment. Responder according to partial Mayo score was defined as a decrease from baseline in partial Mayo score of at least 2 points, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=38 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=39 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
Week 2
|
20 Participants
|
25 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
Week 6
|
28 Participants
|
31 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
Week 14
|
30 Participants
|
33 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
Week 22
|
32 Participants
|
30 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
Week 30
|
33 Participants
|
29 Participants
|
—
|
—
|
|
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
Week 54
|
31 Participants
|
28 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 54Population: The PK population consisted of the all-randomized population who received at least one full dose of study drug at Week 6 or thereafter and who had at least one PK concentration result after Week 6 treatment.
For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration of infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All enrolled patient received CT-P13 IV infusions at Weeks 0 and 2. Patients in SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22. Then, CT-P13 IV was switched to CT-P13 SC at Week 30, and further doses with CT-P13 SC were given up to Week 54. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively. All patients in PK population were analyzed according to the treatment they received.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=63 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=64 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 0
|
23.5432 μg/mL
Standard Deviation 8.43542
|
21.8589 μg/mL
Standard Deviation 7.36954
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 2
|
15.4736 μg/mL
Standard Deviation 9.15888
|
14.0747 μg/mL
Standard Deviation 7.74070
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 6
|
—
|
3.7865 μg/mL
Standard Deviation 2.99669
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 12
|
20.9700 μg/mL
Standard Deviation 9.21851
|
—
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 14
|
—
|
2.9317 μg/mL
Standard Deviation 2.60859
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 20
|
21.4500 μg/mL
Standard Deviation 9.86306
|
—
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 22
|
19.6786 μg/mL
Standard Deviation 8.94416
|
2.4273 μg/mL
Standard Deviation 2.49468
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 24
|
20.1528 μg/mL
Standard Deviation 10.53981
|
—
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 26
|
22.3410 μg/mL
Standard Deviation 9.81672
|
—
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 28
|
21.0978 μg/mL
Standard Deviation 8.98618
|
—
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 36
|
22.1927 μg/mL
Standard Deviation 9.97943
|
18.5974 μg/mL
Standard Deviation 11.41166
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 44
|
22.5780 μg/mL
Standard Deviation 11.72637
|
19.6401 μg/mL
Standard Deviation 10.48885
|
—
|
—
|
|
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Week 52
|
22.7928 μg/mL
Standard Deviation 13.17095
|
20.5784 μg/mL
Standard Deviation 12.45367
|
—
|
—
|
SECONDARY outcome
Timeframe: up to Week 54Population: PD population - The PD population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 SC, CT-P13 IV) at Week 6 or thereafter, and who had at least 1 PD result after Week 6 treatment.
For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of Fecal Calprotectin (FC) between 2 treatment groups up to Week 54. The fecal samples for FC were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. All enrolled patients received CT-P13 IV infusions at Weeks 0 and 2. Then, patients in CT-P13 SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in the CT-P13 IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22 (Weeks 14 and 22). And then, CT-P13 IV was switched to CT-P13 SC based on body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54. All patients in the PD population were analyzed according to the treatment they received.
Outcome measures
| Measure |
Cohort 1: CT-P13 IV 5mg/kg (Part 1)
n=66 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=64 Participants
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
|---|---|---|---|---|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Baseline
|
2094.2 μg/g
Standard Deviation 4114.17
|
2605.2 μg/g
Standard Deviation 8757.77
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 2
|
697.0 μg/g
Standard Deviation 903.85
|
455.0 μg/g
Standard Deviation 561.73
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 6
|
735.3 μg/g
Standard Deviation 1329.11
|
567.3 μg/g
Standard Deviation 956.14
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 14
|
567.6 μg/g
Standard Deviation 751.53
|
706.1 μg/g
Standard Deviation 968.00
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 22
|
796.8 μg/g
Standard Deviation 1950.69
|
1137.0 μg/g
Standard Deviation 2510.62
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 30
|
555.8 μg/g
Standard Deviation 1032.33
|
603.1 μg/g
Standard Deviation 905.60
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 38
|
556.8 μg/g
Standard Deviation 1845.66
|
505.3 μg/g
Standard Deviation 866.04
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 46
|
354.2 μg/g
Standard Deviation 628.37
|
552.2 μg/g
Standard Deviation 1451.62
|
—
|
—
|
|
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Week 54
|
484.1 μg/g
Standard Deviation 1216.95
|
256.2 μg/g
Standard Deviation 520.12
|
—
|
—
|
Adverse Events
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
Serious events: 4 serious events
Other events: 10 other events
Deaths: 1 deaths
Cohort 2: CT-P13 SC 120 mg (Part 1)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 3: CT-P13 SC 180 mg (Part 1)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Cohort 4: CT-P13 SC 240 mg (Part 1)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 1: CT-P13 SC 120/240 mg (Part 2)
Serious events: 6 serious events
Other events: 42 other events
Deaths: 0 deaths
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
n=13 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=11 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
n=12 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
n=8 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
Arm 1: CT-P13 SC 120/240 mg (Part 2)
n=66 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
|
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
n=65 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV were switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Viral infection
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Crohn's disease
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
18.2%
2/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
General disorders
Sudden cardiac death
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
General disorders
Sudden death
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
Other adverse events
| Measure |
Cohort 1: CT-P13 IV 5 mg/kg (Part 1)
n=13 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received further 7 doses of CT-P13 IV 5 mg/kg (Infliximab) by IV infusion at Week 6 and every 8 weeks thereafter up to Week 54.
|
Cohort 2: CT-P13 SC 120 mg (Part 1)
n=11 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 120 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 120 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 2: CT-P13 SC 120 mg.
|
Cohort 3: CT-P13 SC 180 mg (Part 1)
n=12 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 180 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 180 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 3: CT-P13 SC 180 mg.
|
Cohort 4: CT-P13 SC 240 mg (Part 1)
n=8 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC 240 mg (Infliximab) with a 2-week interval from Week 6. The dose of SC 240 mg was adjusted to SC 120 or 240 mg every 2 weeks based on their body weight after Week 30 in applicable patients in Cohort 4: CT-P13 SC 240 mg.
|
Arm 1: CT-P13 SC 120/240 mg (Part 2)
n=66 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 SC (Infliximab) either 120 mg or 240 mg from Week 6 to Week 54 based on their body weight at Week 6 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
|
Arm 2: CT-P13 IV 5 mg/kg (Part 2)
n=65 participants at risk
Each participant received 2 CT-P13 IV infusions with a 2-week interval at Weeks 0 and 2. Then, this group received CT-P13 IV 5 mg/kg (Infliximab) by IV infusion with a 8-week interval from Week 6 up to Week 22 (Weeks 6, 14 and 22). CT-P13 IV were switched to either 120 mg or 240 mg of CT-P13 SC treatment based on their body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54 (CT-P13 SC 120 mg for patients \< 80 kg; CT-P13 SC 240 mg for patients ≥ 80 kg).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
6.1%
4/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
7.6%
5/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.6%
3/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
16.7%
2/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
6/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
6.1%
4/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.3%
8/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
7.6%
5/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
6/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
6/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
General disorders
Localized Injection site reaction
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
25.0%
3/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
22.7%
15/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.6%
3/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
6.1%
4/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
6.1%
4/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
7.6%
5/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
6.2%
4/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
25.0%
2/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
7.6%
5/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.3%
8/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
7.6%
5/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
7.7%
5/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
2/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.0%
2/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Crohn's disease
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
18.2%
2/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.5%
3/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
General disorders
Asthenia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.6%
3/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.0%
2/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
16.7%
2/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.0%
2/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
18.2%
2/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
18.2%
2/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Varicella
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
30.8%
4/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
18.2%
2/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.6%
3/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Delayed hypersensitivity
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.5%
3/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Neutrophil count increased
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Weight decreased
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
Weight increased
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Investigations
White blood cell count increased
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Metabolism and nutrition disorders
Gout
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.6%
3/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.0%
2/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
3.1%
2/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
9.1%
1/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Vascular disorders
Hot flush
|
0.00%
0/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
12.5%
1/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Vascular disorders
Hyperaemia
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
8.3%
1/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
4.5%
3/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
|
General disorders
Pyrexia
|
15.4%
2/13 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/11 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/12 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/8 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
1.5%
1/66 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
0.00%
0/65 • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were assessed from the date the informed consent form was signed until the last assessment date or End-of-Study (EOS) visit.
The investigator was responsible for reporting all AEs that were observed or reported during the study, regardless of their relationship to the study drug or clinical significance. Treatment emergent adverse events were pre-specified to only report the most severe event if the same events were occurred to the same patient. All patients who received at least 1 (partial or full) dose of study drug at Week 6 or thereafter were included in safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place