Trial Outcomes & Findings for Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS) (NCT NCT02764541)
NCT ID: NCT02764541
Last Updated: 2025-05-07
Results Overview
Log fold change in anti-proliferative activity of Letrozole versus Tamoxifen within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma during the window phase. Higher absolute value indicates larger change in the anti-proliferative activity
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
baseline to day 15
Results posted on
2025-05-07
Participant Flow
Three patients withdrew consent before receiving intervention
Participant milestones
| Measure |
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm A Tamoxifen First, Then Arm D Endocrine Alone
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm C Endocrine With Palbociclib
Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm D Endocrine Alone
Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm A Tamoxifen Only
Tamoxifen is given in the window phase for 2 weeks
|
Arm B Letrozole Only
Letrozole is given in the window phase for 2 weeks
|
Arm C Endocrine With Palbociclib Only
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm D Endocrine Alone Only
Endocrine therapy alone is given in the treatment phase for 24 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
21
|
37
|
19
|
1
|
2
|
55
|
21
|
|
Overall Study
COMPLETED
|
33
|
20
|
36
|
16
|
0
|
0
|
52
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
3
|
1
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm A Tamoxifen First, Then Arm D Endocrine Alone
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm C Endocrine With Palbociclib
Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm D Endocrine Alone
Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm A Tamoxifen Only
Tamoxifen is given in the window phase for 2 weeks
|
Arm B Letrozole Only
Letrozole is given in the window phase for 2 weeks
|
Arm C Endocrine With Palbociclib Only
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm D Endocrine Alone Only
Endocrine therapy alone is given in the treatment phase for 24 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Metastasis
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease progression
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Three Cycles completed before surgery
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Patient Compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Insurance reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)
Baseline characteristics by cohort
| Measure |
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib
n=36 Participants
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks.
|
Arm A Tamoxifen First, Then Arm D Endocrine Alone
n=21 Participants
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks.
|
Arm B Letrozole First, Then Arm C Endocrine With Palbociclib
n=37 Participants
Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks.
|
Arm B Letrozole First, Then Arm D Endocrine Alone
n=19 Participants
Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks.
|
Arm A Tamoxifen Only
n=1 Participants
Tamoxifen is given in the window phase for 2 weeks
|
Arm B Letrozole Only
n=2 Participants
Letrozole is given in the window phase for 2 weeks
|
Arm C Endocrine With Palbociclib Only
n=55 Participants
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm D Endocrine Alone Only
n=21 Participants
Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=93 Participants
|
62.0 years
n=4 Participants
|
64.0 years
n=27 Participants
|
65.0 years
n=483 Participants
|
56.0 years
n=36 Participants
|
62.0 years
n=10 Participants
|
49.0 years
n=115 Participants
|
48.0 years
n=40 Participants
|
57.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
55 Participants
n=115 Participants
|
21 Participants
n=40 Participants
|
192 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
19 Participants
n=40 Participants
|
172 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
|
Race
Black or African American
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
11 Participants
n=8 Participants
|
|
Race
White
|
31 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
17 Participants
n=40 Participants
|
169 Participants
n=8 Participants
|
|
Race
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
|
Race
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
|
Race
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Menopausal Status
Post-menopausal
|
35 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
123 Participants
n=8 Participants
|
|
Menopausal Status
Pre-menopausal
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
21 Participants
n=40 Participants
|
69 Participants
n=8 Participants
|
|
Baseline Histology
Invasive Ductal
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
92 Participants
n=8 Participants
|
|
Baseline Histology
Invasive Lobular
|
21 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
84 Participants
n=8 Participants
|
|
Baseline Histology
Both
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
15 Participants
n=8 Participants
|
|
Baseline Histology
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Baseline clinical N stage
N0
|
19 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
102 Participants
n=8 Participants
|
|
Baseline clinical N stage
N1
|
17 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
81 Participants
n=8 Participants
|
|
Baseline clinical N stage
N2
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
|
Baseline clinical N stage
N3
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Baseline clinical N stage
Unknown
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
|
Baseline clinical T stage
T1a
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Baseline clinical T stage
T1b
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Baseline clinical T stage
T1c
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
17 Participants
n=8 Participants
|
|
Baseline clinical T stage
T2
|
20 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
11 Participants
n=40 Participants
|
114 Participants
n=8 Participants
|
|
Baseline clinical T stage
T3
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
52 Participants
n=8 Participants
|
|
Baseline clinical T stage
T4
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
|
Baseline clinical T stage
Unknown
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Baseline Invasive Primary Breast Cancer Stage
I
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
15 Participants
n=8 Participants
|
|
Baseline Invasive Primary Breast Cancer Stage
II
|
26 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
19 Participants
n=40 Participants
|
154 Participants
n=8 Participants
|
|
Baseline Invasive Primary Breast Cancer Stage
III
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
23 Participants
n=8 Participants
|
|
Surgery Type
Breast Conservation/Lumpectomy
|
17 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
85 Participants
n=8 Participants
|
|
Surgery Type
Mastectomy
|
17 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
13 Participants
n=40 Participants
|
93 Participants
n=8 Participants
|
|
Surgery Type
Missing
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
14 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: baseline to day 15Population: Patients both not missing baseline and day15 Ki67 were included into the analysis population
Log fold change in anti-proliferative activity of Letrozole versus Tamoxifen within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma during the window phase. Higher absolute value indicates larger change in the anti-proliferative activity
Outcome measures
| Measure |
Tamoxifen With Invasive Ductal
n=27 Participants
Patients with invasive ductal/both histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Ductal
n=28 Participants
Patients with invasive ductal/both histology receiving Letrozole in the window phase
|
Tamoxifen With Invasive Lobular
n=25 Participants
Patients with invasive lobular histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Lobular
n=25 Participants
Patients with invasive lobular histology receiving Letrozole in the window phase
|
|---|---|---|---|---|
|
Difference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase
|
-0.180 log fold-change
Standard Deviation 2.5
|
-1.304 log fold-change
Standard Deviation 2.2
|
-0.635 log fold-change
Standard Deviation 2.5
|
-1.944 log fold-change
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: day 15 to 24 weeksPopulation: Patients with treatment and surgery are included into the analysis population
Residual Cancer Burden index (RCB) between hormone receptor positive invasive breast cancer patients given endocrine therapy plus palbociclib (Arm C) and endocrine therapy alone (Arm D). RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.
Outcome measures
| Measure |
Tamoxifen With Invasive Ductal
n=128 Participants
Patients with invasive ductal/both histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Ductal
n=60 Participants
Patients with invasive ductal/both histology receiving Letrozole in the window phase
|
Tamoxifen With Invasive Lobular
Patients with invasive lobular histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Lobular
Patients with invasive lobular histology receiving Letrozole in the window phase
|
|---|---|---|---|---|
|
Pathologic Complete Response (pCR) of Patients Given Endocrine Therapy Plus Palbociclib and of Endocrine Therapy Alone During the Treatment Phase
|
2.88 score on a scale
Interval 0.0 to 4.83
|
2.88 score on a scale
Interval 0.03 to 4.71
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to day 15Population: Patients both not missing baseline and day15 Ki67 were included into the analysis population
Odds Ratio of Achieving Cell Cycle Arrest at the end of Window Phase in hormone receptor positive invasive breast cancer patients given Tamoxifen vs Letrozole. Cell cycle arrest is defined to be percentage of Ki67\<2.7
Outcome measures
| Measure |
Tamoxifen With Invasive Ductal
n=55 Participants
Patients with invasive ductal/both histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Ductal
n=50 Participants
Patients with invasive ductal/both histology receiving Letrozole in the window phase
|
Tamoxifen With Invasive Lobular
Patients with invasive lobular histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Lobular
Patients with invasive lobular histology receiving Letrozole in the window phase
|
|---|---|---|---|---|
|
Odds Ratio of Achieving Cell Cycle Arrest at the End of Window Phase
|
0.26 odds ratio
Interval 0.08 to 0.89
|
0.60 odds ratio
Interval 0.19 to 1.9
|
—
|
—
|
SECONDARY outcome
Timeframe: day 15 to 24 weeksPopulation: Patients with treatment and surgery are included into the analysis population
The estimate of RCB index change for patients who receive both endocrine and Palbociclib instead of endocrine alone, but have the same lymph node status, tumor size and menopausal status. RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.
Outcome measures
| Measure |
Tamoxifen With Invasive Ductal
n=128 Participants
Patients with invasive ductal/both histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Ductal
n=60 Participants
Patients with invasive ductal/both histology receiving Letrozole in the window phase
|
Tamoxifen With Invasive Lobular
Patients with invasive lobular histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Lobular
Patients with invasive lobular histology receiving Letrozole in the window phase
|
|---|---|---|---|---|
|
Change in RCB Index Between Arm C and Arm D During the Treatment Phase
|
2.88 units on a scale
Interval 0.0 to 4.83
|
2.88 units on a scale
Interval 0.03 to 4.71
|
—
|
—
|
SECONDARY outcome
Timeframe: day 15 to 24 weeksPopulation: Patients with treatment and surgery are included into the analysis population
RCB response is defined as RCB-0 or RCB-I; RCB not response is defined as RCB-II or RCB-III Residual Cancer Burden (RCB) considers residual disease in the tumor bed and lymph nodes after NAC, generating a continuous score which is then grouped into four categories: RCB-0, RCB-I, RCB-II and RCB-III. Higher RCB group reflects more tumor burden remaining, thus worse outcome
Outcome measures
| Measure |
Tamoxifen With Invasive Ductal
n=128 Participants
Patients with invasive ductal/both histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Ductal
n=60 Participants
Patients with invasive ductal/both histology receiving Letrozole in the window phase
|
Tamoxifen With Invasive Lobular
Patients with invasive lobular histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Lobular
Patients with invasive lobular histology receiving Letrozole in the window phase
|
|---|---|---|---|---|
|
Number of Participants With RCB Response in Arm C and Arm D During the Treatment Phase
|
10 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: day 15 to 24 weeksPopulation: Patients with treatment and surgery are included into the analysis population
Percentage of Participants with Clinical Response in Arm C and Arm D in Breast cancer patients diagnosed with hormone receptor positive invasive breast cancer; Clinical response rate is defined as the number of partial and complete responses after preoperative endocrine therapy plus palbociclib (Arm C) and of endocrine therapy alone (Arm D)
Outcome measures
| Measure |
Tamoxifen With Invasive Ductal
n=128 Participants
Patients with invasive ductal/both histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Ductal
n=60 Participants
Patients with invasive ductal/both histology receiving Letrozole in the window phase
|
Tamoxifen With Invasive Lobular
Patients with invasive lobular histology receiving Tamoxifen in the window phase
|
Letrozole With Invasive Lobular
Patients with invasive lobular histology receiving Letrozole in the window phase
|
|---|---|---|---|---|
|
Percentage of Participants With Clinical Response in Arm C and Arm D in the Treatment Phase
|
57.8 percentage of participants
|
43.3 percentage of participants
|
—
|
—
|
Adverse Events
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib
Serious events: 3 serious events
Other events: 36 other events
Deaths: 1 deaths
Arm A Tamoxifen First, Then Arm D Endocrine Alone
Serious events: 3 serious events
Other events: 21 other events
Deaths: 2 deaths
Arm B Letrozole First, Then Arm C Endocrine With Palbociclib
Serious events: 14 serious events
Other events: 37 other events
Deaths: 0 deaths
Arm B Letrozole First, Then Arm D Endocrine Alone
Serious events: 0 serious events
Other events: 18 other events
Deaths: 1 deaths
Arm A Tamoxifen Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B Letrozole Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm C Endocrine With Palbociclib Only
Serious events: 21 serious events
Other events: 55 other events
Deaths: 3 deaths
Arm D Endocrine Alone Only
Serious events: 0 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib
n=36 participants at risk
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm A Tamoxifen First, Then Arm D Endocrine Alone
n=21 participants at risk
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm C Endocrine With Palbociclib
n=37 participants at risk
Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm D Endocrine Alone
n=19 participants at risk
Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm A Tamoxifen Only
n=1 participants at risk
Tamoxifen is given in the window phase for 2 weeks
|
Arm B Letrozole Only
n=2 participants at risk
Letrozole is given in the window phase for 2 weeks
|
Arm C Endocrine With Palbociclib Only
n=55 participants at risk
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm D Endocrine Alone Only
n=21 participants at risk
Endocrine therapy alone is given in the treatment phase for 24 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Neutrophil count decreased
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
35.1%
13/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
32.7%
18/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
White blood cell decreased
|
2.8%
1/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Fatigue
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
4.8%
1/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
1.8%
1/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
4.8%
1/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
4.8%
1/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
2.7%
1/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
2.7%
1/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
2.7%
1/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
1.8%
1/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Vascular disorders
Hypertension
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
2.7%
1/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
1.8%
1/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
1.8%
1/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
1.8%
1/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
1.8%
1/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
1.8%
1/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
Other adverse events
| Measure |
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib
n=36 participants at risk
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm A Tamoxifen First, Then Arm D Endocrine Alone
n=21 participants at risk
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm C Endocrine With Palbociclib
n=37 participants at risk
Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm B Letrozole First, Then Arm D Endocrine Alone
n=19 participants at risk
Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks
|
Arm A Tamoxifen Only
n=1 participants at risk
Tamoxifen is given in the window phase for 2 weeks
|
Arm B Letrozole Only
n=2 participants at risk
Letrozole is given in the window phase for 2 weeks
|
Arm C Endocrine With Palbociclib Only
n=55 participants at risk
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
|
Arm D Endocrine Alone Only
n=21 participants at risk
Endocrine therapy alone is given in the treatment phase for 24 weeks
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
6/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.8%
4/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.9%
6/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Endocrine disorders
Hypothyroidism
|
13.9%
5/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Eye disorders
Blurred vision
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
8/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
13.5%
5/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
16.4%
9/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
19.0%
4/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
8/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
19.0%
4/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
18.9%
7/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
27.3%
15/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
9/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
18.9%
7/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
31.6%
6/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Mucositis oral
|
27.8%
10/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
27.0%
10/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
27.3%
15/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Nausea
|
36.1%
13/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
18.9%
7/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
15.8%
3/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
25.5%
14/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Chills
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Fatigue
|
75.0%
27/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
42.9%
9/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
70.3%
26/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
52.6%
10/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
50.0%
1/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
61.8%
34/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
28.6%
6/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Fever
|
11.1%
4/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
19.4%
7/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
24.3%
9/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
31.6%
6/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.5%
8/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Pain
|
13.9%
5/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
19.0%
4/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
21.1%
4/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.9%
6/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Infections and infestations
Breast infection
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Infections and infestations
Sinusitis
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.8%
4/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Infections and infestations
Skin infection
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
4/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Cholesterol high
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
26.3%
5/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Creatinine increased
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Neutrophil count decreased
|
77.8%
28/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
62.2%
23/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
78.2%
43/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Platelet count decreased
|
13.9%
5/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.8%
4/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
16.4%
9/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
White blood cell decreased
|
13.9%
5/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
21.8%
12/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
8/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
42.9%
9/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
29.7%
11/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
31.6%
6/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
18.2%
10/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
4/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
21.1%
4/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.8%
4/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
12.7%
7/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
19.0%
4/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
13.5%
5/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
15.8%
3/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.4%
7/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
16.2%
6/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.1%
5/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.5%
2/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
4/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
21.1%
4/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Dizziness
|
13.9%
5/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.8%
4/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
20.0%
11/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Headache
|
22.2%
8/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
16.2%
6/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
15.8%
3/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
36.4%
20/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
19.0%
4/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Psychiatric disorders
Anxiety
|
22.2%
8/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
16.2%
6/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.5%
2/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
30.9%
17/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
19.0%
4/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Psychiatric disorders
Depression
|
13.9%
5/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
19.0%
4/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
13.5%
5/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
21.1%
4/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.5%
8/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Psychiatric disorders
Insomnia
|
22.2%
8/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
32.4%
12/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
36.8%
7/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
32.7%
18/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
38.1%
8/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Reproductive system and breast disorders
Breast pain
|
22.2%
8/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
33.3%
7/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
13.5%
5/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
15.8%
3/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.1%
5/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.1%
5/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.1%
4/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.5%
2/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.1%
5/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.9%
5/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
28.6%
6/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.9%
6/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
2/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other, specify
|
8.3%
3/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Vascular disorders
Hot flashes
|
58.3%
21/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
81.0%
17/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
37.8%
14/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
52.6%
10/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
67.3%
37/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
81.0%
17/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Vascular disorders
Hypertension
|
41.7%
15/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
28.6%
6/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
35.1%
13/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
42.1%
8/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.6%
13/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Edema limbs
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
23.8%
5/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
18.9%
7/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.1%
5/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.5%
2/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.8%
4/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Flu like symptoms
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Localized edema
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
8.1%
3/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Stroke
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
15.8%
3/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.4%
2/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Eye disorders
Cataract
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Eye disorders
Dry eye
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
14.3%
3/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Blood prolactin abnormal
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Investigations
Weight gain
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.3%
1/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
General disorders
Malaise
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
10.9%
6/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
5.5%
3/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.1%
5/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
7.3%
4/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/36 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/37 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/19 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/1 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/2 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
0.00%
0/55 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
9.5%
2/21 • The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place