Trial Outcomes & Findings for Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome (NCT NCT02775916)
NCT ID: NCT02775916
Last Updated: 2021-01-05
Results Overview
Safety and tolerability of CDZ173 in patients with primary Sjögren's syndrome up to End of Treatment Day 85
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
up to Day 85
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
CDZ173
Capsule BID
|
Placebo
Capsule matching Placebo BID
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
17
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
CDZ173
Capsule BID
|
Placebo
Capsule matching Placebo BID
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Subject/Guardian Decision
|
2
|
0
|
Baseline Characteristics
Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome
Baseline characteristics by cohort
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 13.85 • n=99 Participants
|
44.7 years
STANDARD_DEVIATION 11.58 • n=107 Participants
|
47.3 years
STANDARD_DEVIATION 13.07 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to Day 85Population: Safety Analysis Set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the safety analysis set
Safety and tolerability of CDZ173 in patients with primary Sjögren's syndrome up to End of Treatment Day 85
Outcome measures
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
|---|---|---|
|
Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85
Participants with at least one AE
|
20 count of participants
|
8 count of participants
|
|
Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85
Participants with at least one SAE
|
1 count of participants
|
0 count of participants
|
|
Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85
Death
|
0 count of participants
|
0 count of participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks (Day 85)Population: PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set
The ESSPRI is an established disease outcome measure for Sjögren's syndrome. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10.
Outcome measures
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
|---|---|---|
|
Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85
|
-1.778 total score on scale
Standard Deviation 2.4509
|
-0.741 total score on scale
Standard Deviation 1.3517
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks (Day 85)Population: PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set
The ESSDAI is an established disease outcome measure for Sjögren's syndrome. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. A reduction from baseline (i.e., a negative change from baseline) in the ESSDAI score is indicative of improvement in a patient.). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).
Outcome measures
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
|---|---|---|
|
Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85
|
-2.82 total score on scale
Standard Error 1.165
|
-3.34 total score on scale
Standard Error 1.168
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks (Day 85)Population: PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set
The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.
Outcome measures
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
|---|---|---|
|
Change From Baseline in the Short Form (36) Health Survey (SF-36) After 12 Weeks of Treatment Day 85
Physical Component Summary Score
|
4.82 total score on a scale
Standard Error 2.235
|
4.42 total score on a scale
Standard Error 2.425
|
|
Change From Baseline in the Short Form (36) Health Survey (SF-36) After 12 Weeks of Treatment Day 85
Mental Component Summary Score
|
5.43 total score on a scale
Standard Error 3.415
|
1.10 total score on a scale
Standard Error 3.792
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks (Day 85)Population: PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set
The Multidimensional Fatigue Inventory (MFI) is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a possible range from 4-20. The reported total score has a range from 20-100. The reported total score has a range from 20-100, higher scores are associated with greater fatigue.
Outcome measures
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
|---|---|---|
|
Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85)
|
-8.80 total score on scale
Standard Error 5.557
|
-2.25 total score on scale
Standard Error 5.774
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks (Day 85)Population: PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set
A reduction from baseline (i.e., a negative change from baseline) in physician global VAS assessment score indicates improvement in patients. The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Outcome measures
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
|---|---|---|
|
Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (Physician VAS) After 12 Weeks of Treatment Day 85
|
-10.06 total score on a scale
Standard Error 6.584
|
0.91 total score on a scale
Standard Error 7.699
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set
A reduction from baseline (or, a negative change from baseline) in patient global VAS assessment score indicates improvement in patients. The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
Outcome measures
| Measure |
CDZ173
n=20 Participants
Capsule BID
|
Placebo
n=10 Participants
Capsule matching Placebo BID
|
|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85
|
-4.83 total score on a scale
Standard Error 7.268
|
2.87 total score on a scale
Standard Error 8.412
|
Adverse Events
CDZ173
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CDZ173
n=20 participants at risk
Capsule BID
|
Placebo
n=10 participants at risk
Capsule matching Placebo BID
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
Other adverse events
| Measure |
CDZ173
n=20 participants at risk
Capsule BID
|
Placebo
n=10 participants at risk
Capsule matching Placebo BID
|
|---|---|---|
|
Eye disorders
Dry Eye
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
5/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
30.0%
3/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
General disorders
Chest Discomfort
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
General disorders
Chills
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
General disorders
Fatigue
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
General disorders
Feeling Cold
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
General disorders
Pyrexia
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Infections and infestations
Infected Bite
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.0%
3/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
35.0%
7/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
40.0%
4/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Musculoskeletal and connective tissue disorders
Sjogren's Syndrome
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.0%
3/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
15.0%
3/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
2/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
0.00%
0/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
10/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/20 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
10.0%
1/10 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (Day 113)
|
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 or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER