Trial Outcomes & Findings for Study of Efficacy of CDZ173 in Patients With APDS/PASLI (NCT NCT02435173)
NCT ID: NCT02435173
Last Updated: 2022-08-10
Results Overview
Number of participants with AEs and SAEs, including significant changes from baseline in physical findings, vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The number of participants in each category (AEs and SAEs) is reported per dose level: CDZ173 10 mg from Day 1 to Day 28, CDZ173 30 mg from day 29 to day 56 and CDZ173 70 mg from day 57 to day 84.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
37 participants
Primary outcome timeframe
From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days
Results posted on
2022-08-10
Participant Flow
Participants took part in 10 investigative sites in 9 countries.
The participants were screened within 50 days prior to enrollment. After screening and baseline assessments, the treatment period started on Day 1.
Participant milestones
| Measure |
Part I: CDZ173
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: CDZ173 70 mg
Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
21
|
10
|
|
Overall Study
Pharmacokinetics (PK) Analysis Set
|
6
|
19
|
0
|
|
Overall Study
Pharmacodynamic (PD) Analysis Set
|
6
|
19
|
8
|
|
Overall Study
COMPLETED
|
6
|
21
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Efficacy of CDZ173 in Patients With APDS/PASLI
Baseline characteristics by cohort
| Measure |
Part I: CDZ173
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: CDZ173 70 mg
n=21 Participants
Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=10 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
22.2 Years
STANDARD_DEVIATION 5.64 • n=93 Participants
|
22.2 Years
STANDARD_DEVIATION 10.00 • n=4 Participants
|
26.7 Years
STANDARD_DEVIATION 13.43 • n=27 Participants
|
23.43 Years
STANDARD_DEVIATION 10.44 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 daysPopulation: All participants enrolled in Part I.
Number of participants with AEs and SAEs, including significant changes from baseline in physical findings, vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The number of participants in each category (AEs and SAEs) is reported per dose level: CDZ173 10 mg from Day 1 to Day 28, CDZ173 30 mg from day 29 to day 56 and CDZ173 70 mg from day 57 to day 84.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
CDZ173 30 mg AEs
|
2 Participants
|
—
|
—
|
|
Part I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
CDZ173 10 mg AEs
|
2 Participants
|
—
|
—
|
|
Part I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
CDZ173 10 mg SAEs
|
0 Participants
|
—
|
—
|
|
Part I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
CDZ173 30 mg SAEs
|
0 Participants
|
—
|
—
|
|
Part I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
CDZ173 70 mg AEs
|
4 Participants
|
—
|
—
|
|
Part I: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
CDZ173 70 mg SAEs
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 29 and 57 (0.25 and 3 h post morning dose) and Day 84Population: All participants enrolled in Part I
Venous whole blood samples were collected for the assessment of the dose-PD and the PK/PD relationship of CDZ173 in participants with APDS/PASLI for dose selection in Part II. CDZ173 was determined by a validated Liquid chromatography - Mass spectometry (LC-MS) method; anticipated Lower Limit of Quantification (LLOQ) was 3 ng/mL. Concentrations below the LLOQ were reported as "zero" and no methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I: CDZ173 Dose Concentration
Day 1: 0.25 h post-dose
|
10.10 Nanogram / millilitre
Standard Deviation 1.10
|
—
|
—
|
|
Part I: CDZ173 Dose Concentration
Day 1: 3 h post-dose
|
321.00 Nanogram / millilitre
Standard Deviation 115.00
|
—
|
—
|
|
Part I: CDZ173 Dose Concentration
Day 29: 0.25 h post-dose
|
249.00 Nanogram / millilitre
Standard Deviation 540.00
|
—
|
—
|
|
Part I: CDZ173 Dose Concentration
Day 29: 3 h post-dose
|
916.00 Nanogram / millilitre
Standard Deviation 185.00
|
—
|
—
|
|
Part I: CDZ173 Dose Concentration
Day 57: 0.25 h post-dose
|
150.00 Nanogram / millilitre
Standard Deviation 143.00
|
—
|
—
|
|
Part I: CDZ173 Dose Concentration
Day 57: 3 h post-dose
|
1710.00 Nanogram / millilitre
Standard Deviation 782.00
|
—
|
—
|
|
Part I: CDZ173 Dose Concentration
Day 84
|
998.00 Nanogram / millilitre
Standard Deviation 455.00
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, days 29 and 57 (3 and 12 h post-dose) and day 84Population: All participants who were enrolled in Part I. At each time point, only participants with a derived baseline value and a result at that time point were included.
Phosphorylation of Akt in ex vivo stimulated and unstimulated B cells was quantified at baseline and at the end of the 4-week treatment period for each of the three dose levels. Determination of the percentage (%) of CD20B+ phospho-Akt positive cells after ex vivo stimulation of whole blood was performed by flow cytometry analysis. The percentage of inhibition of pAkt was defined as (-1) \* percent change from baseline pAkt value. Unstimulated cells served as controls at each time point. Baseline was defined as the mean of the day -1 value and the pre-dose value on Day 1 when both were available (if one was missing, then baseline was defined as the existing value). A higher percentage of inhibition of stimulated B cells indicates improvement. No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Unstimulated: Day 29 - 3 h post-dose
|
82.07 Percentage
Standard Deviation 7.25
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Stimulated: Day 29 - 3 h post-dose
|
78.00 Percentage
Standard Deviation 7.25
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Unstimulated: Day 29 - 12 h post-dose
|
50.58 Percentage
Standard Deviation 18.73
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Stimulated: Day 29 - 12 h post-dose
|
47.14 Percentage
Standard Deviation 7.83
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Unstimulated: Day 57 - 3 h post-dose
|
86.61 Percentage
Standard Deviation 5.26
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Stimulated: Day 57 - 3 h post-dose
|
60.98 Percentage
Standard Deviation 54.05
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Unstimulated: Day 57 - 12 h post-dose
|
53.18 Percentage
Standard Deviation 16.59
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Stimulated: Day 57 - 12 h post-dose
|
63.65 Percentage
Standard Deviation 21.03
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Unstimulated: Day 84
|
74.35 Percentage
Standard Deviation 11.03
|
—
|
—
|
|
Part I: Percentage of Inhibition of Unstimulated and Stimulated pAkt Levels in B Cells
CD20B Stimulated: Day 84
|
78.65 Percentage
Standard Deviation 12.00
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Day 85Population: Pharmacodynamic (PD) analysis set, excluding participants with 0 lesion at baseline. Only participants with baseline and end of treatment lymphadenopathy measurements were included.
For the assessment of the impact of CDZ173 on lymphadenopathy, participants were scanned in a magnetic resonance imaging (MRI) or a computed tomography (CT) scanner as based on clinical practice and local regulation. MRI or CT imaging of the neck, chest, abdomen and pelvis was performed. Index lesions were selected from measurable nodal and extranodal lesions as per the Cheson methodology. A maximum of six of the largest dominant lesions were selected and documented at baseline and assessed again at the end of treatment. The change in lymph node size was measured using the log10 transformed sum of product of diameters (SPD), the sum of the longest lesion diameter (mm)" and "longest perpendicular diameter (mm)". A lower score indicates index lesions SPD reduction. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=18 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: Change From Baseline in the log10 Transformed Sum of Product of Diameters (SPD) in the Index Lesions
|
-0.30 Millimeter on Log10 scale
Standard Error 0.04
|
-0.06 Millimeter on Log10 scale
Standard Error 0.06
|
—
|
PRIMARY outcome
Timeframe: Baseline and Day 85Population: Pharmacodynamic (PD) analysis set. Only participants with a percentage of less than 48% of naive B cells at baseline and with a measured value at Day 85 were included.
APDS/PASLI patients suffer from dysregulation in B cell function and differentiation with low numbers of naive B cells. Change from baseline in percentage of naïve B cells out of total B cells at the end of treatment was assessed by flow cytometry to evaluate the pharmacodynamic effect of CDZ173 on B cell immunophenotyping. A higher percentage in naïve B out of total B cells is a positive outcome. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=8 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=5 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: Change From Baseline in Percentage of naïve B Cells Out of Total B Cells
|
34.76 Percentage change from baseline
Standard Error 3.08
|
-5.37 Percentage change from baseline
Standard Error 3.95
|
—
|
SECONDARY outcome
Timeframe: Part I: Days 1, 29 and 57 / Part II: Day 1Population: Pharmacokinetics (PK) Analysis Set
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods. AUClast was calculated at the first day of every CDZ173 dose level (10, 30 and 70 mg) for Part I and (70 mg) for Part II. No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=19 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for CDZ173
Day 1
|
1760.0 Hour * nanogram / millilitre
Standard Deviation 441.0
|
10400.0 Hour * nanogram / millilitre
Standard Deviation 2800.0
|
—
|
|
Part I & II: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for CDZ173
Day 29
|
4760.0 Hour * nanogram / millilitre
Standard Deviation 816.0
|
—
|
—
|
|
Part I & II: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for CDZ173
Day 57
|
10800.0 Hour * nanogram / millilitre
Standard Deviation 3310.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Part I: Days 1, 29 and 57 / Part II: Day 1Population: Pharmacokinetics (PK) Analysis Set
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods. Cmax was calculated at the first day of every CDZ173 dose level (10, 30 and 70 mg) for Part I and (70 mg) for Part II. No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=19 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Maximum Observed Plasma Concentration (Cmax) for CDZ173
Day 1
|
393.0 Nanogram / millilitre
Standard Deviation 137.0
|
2150.0 Nanogram / millilitre
Standard Deviation 576.0
|
—
|
|
Part I & II: Maximum Observed Plasma Concentration (Cmax) for CDZ173
Day 29
|
1060.0 Nanogram / millilitre
Standard Deviation 222.0
|
—
|
—
|
|
Part I & II: Maximum Observed Plasma Concentration (Cmax) for CDZ173
Day 57
|
2540.0 Nanogram / millilitre
Standard Deviation 747.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Part I: Baseline and Days 29, 57 and 84 / Part II: Baseline and Days 29, 57 and 85Population: Pharmacodynamic (PD) analysis set
The SF-36 is a widely used and extensively studied instrument to measure health-related quality of life (HRQoL) among healthy subjects and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The subscales are aggregated to derive two overall summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores. PCS and MCS scores range from 0 to 100 with a higher score indicating a more favorable health state (range = 0 "worst" - 100 "best"). No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=19 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day 57: Physical Component Summary
|
47.54 Score on a scale
Standard Deviation 9.24
|
47.04 Score on a scale
Standard Deviation 7.30
|
47.20 Score on a scale
Standard Deviation 9.75
|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day -1: Mental Component Summary
|
47.94 Score on a scale
Standard Deviation 8.22
|
47.36 Score on a scale
Standard Deviation 7.98
|
45.94 Score on a scale
Standard Deviation 8.14
|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day -1: Physical Component Summary
|
47.54 Score on a scale
Standard Deviation 9.24
|
44.49 Score on a scale
Standard Deviation 7.08
|
44.06 Score on a scale
Standard Deviation 8.59
|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day 29: Mental Component Summary
|
47.94 Score on a scale
Standard Deviation 8.22
|
49.98 Score on a scale
Standard Deviation 8.06
|
49.52 Score on a scale
Standard Deviation 6.70
|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day 29: Physical Component Summary
|
47.54 Score on a scale
Standard Deviation 9.24
|
47.87 Score on a scale
Standard Deviation 7.66
|
44.62 Score on a scale
Standard Deviation 7.57
|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day 57: Mental Component Summary
|
47.94 Score on a scale
Standard Deviation 8.22
|
49.12 Score on a scale
Standard Deviation 8.17
|
45.92 Score on a scale
Standard Deviation 7.31
|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day 84 (Part I) / Day 85 (Part II): Mental Component Summary
|
47.94 Score on a scale
Standard Deviation 8.22
|
49.22 Score on a scale
Standard Deviation 8.17
|
47.32 Score on a scale
Standard Deviation 8.73
|
|
Part I & II: Mental Component Summary (MCS) and Physical Component Summary (PCS) From Short Form 36 (SF-36) Survey
Day 84 (Part I) / Day 85 (Part II): Physical Component Summary
|
47.54 Score on a scale
Standard Deviation 9.24
|
47.59 Score on a scale
Standard Deviation 6.22
|
47.48 Score on a scale
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: Part I: Baseline and Days 29, 57 and 84 / Part II: Baseline and Days 29, 57 and 85Population: Pharmacodynamic (PD) analysis set. Only the participants that responded the work-related questions from the WPAI-CIQ and with a value at both baseline and that time point were included.
The Work Productivity Activity Impairment (WPAI) questionnaire measures the amount of absence or presence for work attendance and daily work activity impairment attributable to APDS/PASLI. As younger participants (age 12 and above) were enrolled in the study the WPAI-CIQ was used for all participants as it also measures the amount of absence or presence for school attendance and daily classroom activity impairment. Participants responded for classroom or work-related questions depending on their situation. WPAI-CIQ consists of 10 questions that yield 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. The Overall work impairment due to health (%) score ranges from 0 to 100% with 100% indicating total work impairment and 0% no impairment at all. No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=2 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=9 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=2 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Overall Work Impairment Due to Health Score From Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Baseline
|
25.00 Percentage
Standard Deviation 35.36
|
51.25 Percentage
Standard Deviation 37.23
|
5.00 Percentage
Standard Deviation 7.07
|
|
Part I & II: Overall Work Impairment Due to Health Score From Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Day 29
|
44.00 Percentage
Standard Deviation 0
|
35.31 Percentage
Standard Deviation 23.12
|
5.00 Percentage
Standard Deviation 7.07
|
|
Part I & II: Overall Work Impairment Due to Health Score From Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Day 57
|
62.31 Percentage
Standard Deviation 0
|
35.49 Percentage
Standard Deviation 24.70
|
10.00 Percentage
Standard Deviation 14.14
|
|
Part I & II: Overall Work Impairment Due to Health Score From Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Day 84 (Part I) / Day 85 (Part II)
|
44.41 Percentage
Standard Deviation 7.90
|
35.59 Percentage
Standard Deviation 31.85
|
25.00 Percentage
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Part I: Baseline and Days 29, 57 and 84 / Part II: Baseline and Days 29, 57 and 85Population: Pharmacodynamic (PD) analysis set. Only the participants that responded the classroom-related questions from the WPAI-CIQ and with a value at both baseline and that time point were included.
The Work Productivity Activity Impairment (WPAI) questionnaire measures the amount of absence or presence for work attendance and daily work activity impairment attributable to APDS/PASLI. As younger participants (age 12 and above) were enrolled in the study the WPAI-CIQ was used for all participants as it also measures the amount of absence or presence for school attendance and daily classroom activity impairment. Participants responded for classroom or work-related questions depending on their situation. WPAI-CIQ consists of 10 questions that yield 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. The Overall classroom impairment due to health (%) score ranges from 0 to 100% with 100% indicating total classroom impairment and 0% no impairment at all. A higher percentage indicates a negative outcome. No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=3 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=5 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=4 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Overall Classroom Impairment Due to Health Score From the Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Baseline
|
65.68 Percentage
Standard Deviation 33.49
|
47.33 Percentage
Standard Deviation 44.75
|
23.75 Percentage
Standard Deviation 30.92
|
|
Part I & II: Overall Classroom Impairment Due to Health Score From the Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Day 29
|
57.30 Percentage
Standard Deviation 18.09
|
0.00 Percentage
Standard Deviation 0
|
22.65 Percentage
Standard Deviation 24.37
|
|
Part I & II: Overall Classroom Impairment Due to Health Score From the Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Day 57
|
70.13 Percentage
Standard Deviation 18.68
|
12.14 Percentage
Standard Deviation 3.03
|
22.40 Percentage
Standard Deviation 26.16
|
|
Part I & II: Overall Classroom Impairment Due to Health Score From the Work Productivity Activity Impairment and Classroom Impairment Questionnaire (WPAI-CIQ)
Day 84 (Part I) / Day 85 (Part II)
|
68.52 Percentage
Standard Deviation 18.74
|
51.00 Percentage
Standard Deviation 0.00
|
5.00 Percentage
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Part I: Baseline and Days 29, 57 and 84 / Part II: Baseline and Days 29, 57 and 85Population: Pharmacodynamic (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.
In the physician's global assessment questionnaire the Investigator rated the disease activity of their patient using 100 mm Visual analogue Scale (VAS) ranging from "no disease activity" (0) to "maximal disease activity" (100). To enhance objectivity, the physician was not aware of the specific patient's global assessment, when performing his own assessment on that patient. No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=19 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Physician's Global Assessment (PGA)
Baseline
|
34.7 Score on a scale
Standard Deviation 17.07
|
47.10 Score on a scale
Standard Deviation 17.65
|
41.38 Score on a scale
Standard Deviation 17.78
|
|
Part I & II: Physician's Global Assessment (PGA)
Day 29
|
21.8 Score on a scale
Standard Deviation 9.70
|
38.81 Score on a scale
Standard Deviation 23.73
|
29.75 Score on a scale
Standard Deviation 9.99
|
|
Part I & II: Physician's Global Assessment (PGA)
Day 57
|
22.5 Score on a scale
Standard Deviation 13.55
|
34.02 Score on a scale
Standard Deviation 18.89
|
24.13 Score on a scale
Standard Deviation 18.34
|
|
Part I & II: Physician's Global Assessment (PGA)
Day 84 (Part I) / Day 85 (Part II)
|
8.8 Score on a scale
Standard Deviation 4.12
|
26.70 Score on a scale
Standard Deviation 22.82
|
25.88 Score on a scale
Standard Deviation 16.15
|
SECONDARY outcome
Timeframe: Part I: Baseline and Days 29, 57 and 84 / Part II: Baseline and Days 29, 57 and 85Population: Pharmacodynamic (PD) analysis set
In the patient's global assessment questionnaire patients are asked about their APDS/PASLI related well-being using 100 mm visual analogue scale (VAS) ranging from "very poor" (0) to "very good" (100). No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=19 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Patient's Global Assessment (PtGA)
Baseline
|
62.0 Score on a Scale
Standard Deviation 21.90
|
54.53 Score on a Scale
Standard Deviation 21.47
|
62.50 Score on a Scale
Standard Deviation 26.56
|
|
Part I & II: Patient's Global Assessment (PtGA)
Day 29
|
65.0 Score on a Scale
Standard Deviation 22.21
|
68.37 Score on a Scale
Standard Deviation 19.31
|
57.75 Score on a Scale
Standard Deviation 24.03
|
|
Part I & II: Patient's Global Assessment (PtGA)
Day 57
|
67.5 Score on a Scale
Standard Deviation 21.83
|
64.79 Score on a Scale
Standard Deviation 19.61
|
69.50 Score on a Scale
Standard Deviation 21.93
|
|
Part I & II: Patient's Global Assessment (PtGA)
Day 84 (Part I) / Day 85 (Part II)
|
72.5 Score on a Scale
Standard Deviation 13.37
|
67.58 Score on a Scale
Standard Deviation 16.57
|
60.25 Score on a Scale
Standard Deviation 23.66
|
SECONDARY outcome
Timeframe: Part I: Baseline and Days 1, 15, 29, 57, 84 / Part II: Baseline and Days 1, 15, 29, 57, 85Population: Pharmacodynamic (PD) analysis set. At each time point, only participants with a value at that time point were included (no imputation for missing data).
High Sensitivity C reactive protein is a blood test biomarker for inflammation in the body. Sequential blood samples were collected in all participants. HsCRP was measured in serum using a latex immunochemilunminometric assay (ICMA). No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=19 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: High Sensivity C Reactive Protein (hsCRP) as Biomarker for Systemic Inflammation
Baseline
|
2.49 Milligram / liter
Standard Deviation 1.29
|
10.58 Milligram / liter
Standard Deviation 17.84
|
5.70 Milligram / liter
Standard Deviation 2.19
|
|
Part I & II: High Sensivity C Reactive Protein (hsCRP) as Biomarker for Systemic Inflammation
Day 1
|
2.43 Milligram / liter
Standard Deviation 1.43
|
8.95 Milligram / liter
Standard Deviation 14.56
|
7.85 Milligram / liter
Standard Deviation 4.88
|
|
Part I & II: High Sensivity C Reactive Protein (hsCRP) as Biomarker for Systemic Inflammation
Day 15
|
0.93 Milligram / liter
Standard Deviation 0.70
|
9.19 Milligram / liter
Standard Deviation 23.12
|
2.06 Milligram / liter
Standard Deviation 1.02
|
|
Part I & II: High Sensivity C Reactive Protein (hsCRP) as Biomarker for Systemic Inflammation
Day 29
|
0.77 Milligram / liter
Standard Deviation 0.36
|
5.55 Milligram / liter
Standard Deviation 11.21
|
2.40 Milligram / liter
Standard Deviation 1.75
|
|
Part I & II: High Sensivity C Reactive Protein (hsCRP) as Biomarker for Systemic Inflammation
Day 57
|
1.20 Milligram / liter
Standard Deviation 0.71
|
6.57 Milligram / liter
Standard Deviation 9.18
|
8.90 Milligram / liter
Standard Deviation 16.66
|
|
Part I & II: High Sensivity C Reactive Protein (hsCRP) as Biomarker for Systemic Inflammation
Day 84 (Part I) / Day 85 (Part II)
|
2.82 Milligram / liter
Standard Deviation 4.11
|
7.54 Milligram / liter
Standard Deviation 18.37
|
2.65 Milligram / liter
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Part I: Baseline and Days 1, 15, 29, 57, 84 / Part II: Baseline and Days 1, 15, 29, 57, 85Population: Pharmacodynamic (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.
Lactate dehydrogenase is a blood test biomarker for inflammation in the body. Sequential blood samples were collected in all participants. LDH was measured in serum using a latex immunochemilunminometric assay (ICMA). No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=6 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=19 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part I & II: Lactate Dehydrogenase (LDH) as Biomarker for Systemic Inflammation
Day 29
|
125.17 Units / liter
Standard Deviation 9.85
|
227.17 Units / liter
Standard Deviation 163.41
|
185.25 Units / liter
Standard Deviation 51.62
|
|
Part I & II: Lactate Dehydrogenase (LDH) as Biomarker for Systemic Inflammation
Baseline
|
130.42 Units / liter
Standard Deviation 18.28
|
172.92 Units / liter
Standard Deviation 72.25
|
169.38 Units / liter
Standard Deviation 41.95
|
|
Part I & II: Lactate Dehydrogenase (LDH) as Biomarker for Systemic Inflammation
Day 1
|
132.17 Units / liter
Standard Deviation 23.10
|
170.88 Units / liter
Standard Deviation 72.28
|
175.71 Units / liter
Standard Deviation 53.72
|
|
Part I & II: Lactate Dehydrogenase (LDH) as Biomarker for Systemic Inflammation
Day 15
|
132.17 Units / liter
Standard Deviation 11.44
|
190.94 Units / liter
Standard Deviation 71.54
|
155.14 Units / liter
Standard Deviation 48.09
|
|
Part I & II: Lactate Dehydrogenase (LDH) as Biomarker for Systemic Inflammation
Day 57
|
135.50 Units / liter
Standard Deviation 17.66
|
193.11 Units / liter
Standard Deviation 64.75
|
167.14 Units / liter
Standard Deviation 40.45
|
|
Part I & II: Lactate Dehydrogenase (LDH) as Biomarker for Systemic Inflammation
Day 84 (Part I) / Day 85 (Part II)
|
142.60 Units / liter
Standard Deviation 18.53
|
190.63 Units / liter
Standard Deviation 57.62
|
179.13 Units / liter
Standard Deviation 73.96
|
SECONDARY outcome
Timeframe: Baseline and Days 1, 15, 29, 57, 85Population: Pharmacodynamic (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.
Beta2 microglobulin is a blood test biomarker for inflammation in the body. Sequential blood samples were collected in all participants. Beta2 microglobulin was measured in serum using a latex immunochemilunminometric assay (ICMA). No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=19 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: Beta2 Microglobulin as Biomarker for Systemic Inflammation
Baseline
|
2.46 Milligram / liter
Standard Deviation 0.87
|
2.32 Milligram / liter
Standard Deviation 0.96
|
—
|
|
Part II: Beta2 Microglobulin as Biomarker for Systemic Inflammation
Day 1
|
2.43 Milligram / liter
Standard Deviation 0.88
|
2.31 Milligram / liter
Standard Deviation 0.95
|
—
|
|
Part II: Beta2 Microglobulin as Biomarker for Systemic Inflammation
Day 15
|
2.10 Milligram / liter
Standard Deviation 1.03
|
2.31 Milligram / liter
Standard Deviation 1.09
|
—
|
|
Part II: Beta2 Microglobulin as Biomarker for Systemic Inflammation
Day 29
|
2.02 Milligram / liter
Standard Deviation 1.17
|
3.21 Milligram / liter
Standard Deviation 1.61
|
—
|
|
Part II: Beta2 Microglobulin as Biomarker for Systemic Inflammation
Day 57
|
1.90 Milligram / liter
Standard Deviation 0.72
|
2.42 Milligram / liter
Standard Deviation 1.17
|
—
|
|
Part II: Beta2 Microglobulin as Biomarker for Systemic Inflammation
Day 85
|
2.01 Milligram / liter
Standard Deviation 1.04
|
2.57 Milligram / liter
Standard Deviation 1.19
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 1, 15, 29, 57, 85Population: Pharmacodynamic (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.
Ferritin is a blood test biomarker for inflammation in the body. Sequential blood samples were collected in all participants. Ferritin was measured in serum using a Electrochemiluminescence immunoassay (ECLIA). No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=19 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: Ferritin as Biomarker for Systemic Inflammation
Baseline
|
139.16 Microgram / liter
Standard Deviation 399.73
|
62.05 Microgram / liter
Standard Deviation 81.65
|
—
|
|
Part II: Ferritin as Biomarker for Systemic Inflammation
Day 1
|
142.67 Microgram / liter
Standard Deviation 411.57
|
61.34 Microgram / liter
Standard Deviation 82.04
|
—
|
|
Part II: Ferritin as Biomarker for Systemic Inflammation
Day 15
|
146.99 Microgram / liter
Standard Deviation 494.88
|
24.61 Microgram / liter
Standard Deviation 17.41
|
—
|
|
Part II: Ferritin as Biomarker for Systemic Inflammation
Day 29
|
187.65 Microgram / liter
Standard Deviation 641.16
|
48.43 Microgram / liter
Standard Deviation 61.83
|
—
|
|
Part II: Ferritin as Biomarker for Systemic Inflammation
Day 57
|
199.97 Microgram / liter
Standard Deviation 657.31
|
51.40 Microgram / liter
Standard Deviation 64.95
|
—
|
|
Part II: Ferritin as Biomarker for Systemic Inflammation
Day 85
|
139.42 Microgram / liter
Standard Deviation 368.68
|
63.16 Microgram / liter
Standard Deviation 56.64
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 1, 15, 29, 57, 85Population: Pharmacodynamic (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.
Fibrinogen is a blood test biomarker for inflammation in the body. Sequential blood samples were collected in all participants. Fibrinogen was measured in serum using an Electrochemiluminescence immunoassay (ECLIA). No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=19 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: Fibrinogen as Biomarker for Systemic Inflammation
Baseline
|
2.66 Gram / liter
Standard Deviation 0.76
|
2.68 Gram / liter
Standard Deviation 0.44
|
—
|
|
Part II: Fibrinogen as Biomarker for Systemic Inflammation
Day 1
|
2.61 Gram / liter
Standard Deviation 0.81
|
2.65 Gram / liter
Standard Deviation 0.42
|
—
|
|
Part II: Fibrinogen as Biomarker for Systemic Inflammation
Day 15
|
2.65 Gram / liter
Standard Deviation 0.62
|
2.67 Gram / liter
Standard Deviation 0.42
|
—
|
|
Part II: Fibrinogen as Biomarker for Systemic Inflammation
Day 29
|
2.53 Gram / liter
Standard Deviation 0.54
|
2.66 Gram / liter
Standard Deviation 0.58
|
—
|
|
Part II: Fibrinogen as Biomarker for Systemic Inflammation
Day 57
|
3.01 Gram / liter
Standard Deviation 0.68
|
2.83 Gram / liter
Standard Deviation 1.13
|
—
|
|
Part II: Fibrinogen as Biomarker for Systemic Inflammation
Day 85
|
2.81 Gram / liter
Standard Deviation 0.57
|
2.61 Gram / liter
Standard Deviation 0.57
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 1, 15, 29, 57, 85Population: Pharmacodynamic (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included.
Erythrocyte sedimentation rate (ESR) is a blood test biomarker for inflammation in the body. Sequential blood samples were collected in all participants. ESR was measured in whole blood using the Westergren method. No methods for imputation of missing data were used.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=19 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: Erythrocyte Sedimentation Rate (ESR) as Biomarker for Systemic Inflammation
Baseline
|
28.09 Millimeter / hour
Standard Deviation 19.79
|
25.44 Millimeter / hour
Standard Deviation 24.88
|
—
|
|
Part II: Erythrocyte Sedimentation Rate (ESR) as Biomarker for Systemic Inflammation
Day 1
|
26.88 Millimeter / hour
Standard Deviation 19.33
|
25.13 Millimeter / hour
Standard Deviation 24.51
|
—
|
|
Part II: Erythrocyte Sedimentation Rate (ESR) as Biomarker for Systemic Inflammation
Day 15
|
19.50 Millimeter / hour
Standard Deviation 13.52
|
16.00 Millimeter / hour
Standard Deviation 12.21
|
—
|
|
Part II: Erythrocyte Sedimentation Rate (ESR) as Biomarker for Systemic Inflammation
Day 29
|
18.33 Millimeter / hour
Standard Deviation 13.80
|
26.00 Millimeter / hour
Standard Deviation 25.26
|
—
|
|
Part II: Erythrocyte Sedimentation Rate (ESR) as Biomarker for Systemic Inflammation
Day 57
|
18.06 Millimeter / hour
Standard Deviation 15.36
|
27.88 Millimeter / hour
Standard Deviation 23.04
|
—
|
|
Part II: Erythrocyte Sedimentation Rate (ESR) as Biomarker for Systemic Inflammation
Day 85
|
16.35 Millimeter / hour
Standard Deviation 15.99
|
19.63 Millimeter / hour
Standard Deviation 18.03
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 85Population: Pharmacodynamic (PD) analysis set.
Participants were scanned in a magnetic resonance imaging (MRI) or a computed tomography (CT) scanner as based on clinical practice and local regulation. MRI or CT imaging of the neck, chest, abdomen and pelvis was performed. The 3D volume of index lesions was identified as per the Cheson criteria. A reduction of the 3D volume of the index lesions indicated a positive outcome.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=19 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: 3D Volume of Index Lesions
Baseline
|
20142.12 Millimeter^3
Standard Deviation 15617.13
|
37123.69 Millimeter^3
Standard Deviation 67325.94
|
—
|
|
Part II: 3D Volume of Index Lesions
Day 85
|
7858.08 Millimeter^3
Standard Deviation 6290.98
|
40169.28 Millimeter^3
Standard Deviation 81844.45
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 85Population: Pharmacodynamic (PD) analysis set.
Participants were scanned in a magnetic resonance imaging (MRI) or a computed tomography (CT) scanner as based on clinical practice and local regulation. MRI or CT imaging of the spleen was performed and its 3D volume was identified as per the Cheson criteria. A reduction of the spleen volume indicated a positive outcome.
Outcome measures
| Measure |
Part I: CDZ173 10 mg
n=19 Participants
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: Placebo
n=8 Participants
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|
|
Part II: 3D Volume of the Spleen
Baseline
|
586448.74 Millimeter^3
Standard Deviation 311482.61
|
448456.15 Millimeter^3
Standard Deviation 328641.78
|
—
|
|
Part II: 3D Volume of the Spleen
Day 85
|
411130.98 Millimeter^3
Standard Deviation 193977.46
|
480333.09 Millimeter^3
Standard Deviation 445371.99
|
—
|
Adverse Events
Part I: CDZ173 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I: CDZ173 30 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part I: CDZ173 70 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part I: Total
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part II: CDZ173 70 mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Part II: Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part I: CDZ173 10 mg
n=6 participants at risk
Participants received CDZ173 10 mg b.i.d. from Day 1 to Day 28.
|
Part I: CDZ173 30 mg
n=6 participants at risk
Participants received CDZ173 30 mg b.i.d. from Day 29 to Day 56.
|
Part I: CDZ173 70 mg
n=6 participants at risk
Participants received CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part I: Total
n=6 participants at risk
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: CDZ173 70 mg
n=21 participants at risk
Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=10 participants at risk
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Nervous system disorders
Coma
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Social circumstances
Dependence on oxygen therapy
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
Other adverse events
| Measure |
Part I: CDZ173 10 mg
n=6 participants at risk
Participants received CDZ173 10 mg b.i.d. from Day 1 to Day 28.
|
Part I: CDZ173 30 mg
n=6 participants at risk
Participants received CDZ173 30 mg b.i.d. from Day 29 to Day 56.
|
Part I: CDZ173 70 mg
n=6 participants at risk
Participants received CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part I: Total
n=6 participants at risk
Participants consecutively received CDZ173 10 mg b.i.d. from Day 1 to Day 28, CDZ173 30 mg b.i.d. from Day 29 to Day 56 and CDZ173 70 mg b.i.d. from Day 57 to Day 84.
|
Part II: CDZ173 70 mg
n=21 participants at risk
Participants received CDZ173 70 mg b.i.d. from Day 1 to Day 85.
|
Part II: Placebo
n=10 participants at risk
Participants received Placebo b.i.d. from Day 1 to Day 85.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Congenital, familial and genetic disorders
Methylenetetrahydrofolate reductase gene mutation
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Eye disorders
Episcleritis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
30.0%
3/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
20.0%
2/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
General disorders
Vascular device occlusion
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Groin infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
19.0%
4/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
20.0%
2/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Amylase increased
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
23.8%
5/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
20.0%
2/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
9.5%
2/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
16.7%
1/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
4.8%
1/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/6 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
0.00%
0/21 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
10.0%
1/10 • Part I and Part II: Adverse events (AEs) were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 114 days for Part I and 115 days for Part II. For the subset of participants in Part II that rolled over to the extension study (CCDZ173X2201E1) directly after the last treatment dose in Part II, AEs were reported from the start of treatment to end of treatment, assessed up to maximum duration of 85 days.
Any sign or symptom that occurs during the study treatment plus 30 days post treatment. For Part I AEs were reported based on the CDZ173 dose level received when AE started. Therefore, the 30 days post treatment were only applicable for the CDZ173 70 mg arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER