Trial Outcomes & Findings for Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis (NCT NCT02565576)
NCT ID: NCT02565576
Last Updated: 2021-01-05
Results Overview
QMG score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
week 25
Results posted on
2021-01-05
Participant Flow
A total of 44 patients were randomized to receive either IV CFZ533 or IV placebo, of which 34 patients (77%) completed the study.
Safety analysis set, and Full analysis: 44 patients (22 treated with CFZ533 and 22 with placebo) PK analysis set : 20 patients treated with CFZ533 PD analysis set: 42 patients (20 treated with CFZ533 and 20 with placebo)
Participant milestones
| Measure |
CFZ533
CFZ533 10 mg/kg
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
CFZ533
CFZ533 10 mg/kg
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
abnormal lab value
|
2
|
0
|
|
Overall Study
subject / guardian decision
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis
Baseline characteristics by cohort
| Measure |
CFZ533
n=22 Participants
CFZ533 10 mg/kg
|
Placebo
n=22 Participants
Placebo
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 13.54 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 13.92 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 13.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
caucasian
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Chinese)
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 25Population: pharmacodynamic (PD) analysis set, participants with non-detectable AChR or MuSK autoantibodies were excluded from the PD analysis set.
QMG score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005).
Outcome measures
| Measure |
CFZ533
n=18 Participants
CFZ533 10 mg/kg
|
Placebo
n=18 Participants
Placebo
|
|---|---|---|
|
Mean Change From Baseline in the Quantitative Myastenia Gravis (QMG) Score at Week 25. Posterior Median Was Used as Measure Type.
|
-4.07 score
Interval -5.67 to -2.47
|
-2.93 score
Interval -4.53 to -1.33
|
SECONDARY outcome
Timeframe: From baseline to week 49The Myasthenia Gravis Composite (MGC) score is another key efficacy outcome measure, ranging from 0 to 50. It is reliable and demonstrates concurrent and longitudinal construct validity in the MG practice care setting (Burns et al 2010). The MGC scale covers 10 important functional domains most frequently involved in patients with MG. The proportion of bulbar and respiratory items reflect the clinical importance of these domains in the disease, and are appropriately weighted. The assessment of each of the 10 test items provides immediate insight into the status of that particular functional domain. A decrease in this score shows an improvement.
Outcome measures
| Measure |
CFZ533
n=18 Participants
CFZ533 10 mg/kg
|
Placebo
n=18 Participants
Placebo
|
|---|---|---|
|
Mean Changes From Baseline in the Myasthenia Gravis Composite (MGC) Score. Posterior Median Was Used as Measure Type.
|
-8.00 score
Interval -9.83 to -6.16
|
-5.62 score
Interval -7.45 to -3.78
|
SECONDARY outcome
Timeframe: at week 49Population: PD analysis set, participants with measure
QMG score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005).
Outcome measures
| Measure |
CFZ533
n=18 Participants
CFZ533 10 mg/kg
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|
|
Proportion of Patients With Improvement or Worsening by ≥ 3 Points in the QMG Score
improvement by ≥ 3 points in the QMG score
|
10 Participants
|
9 Participants
|
|
Proportion of Patients With Improvement or Worsening by ≥ 3 Points in the QMG Score
worsening by ≥ 3 points in the QMG score
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: week 49Population: this data was not collected. No analysis could be performed for this outcome measure.
Outcome measures
| Measure |
CFZ533
n=22 Participants
CFZ533 10 mg/kg
|
Placebo
n=22 Participants
Placebo
|
|---|---|---|
|
Proportion of Patients Intolerant to Steroid Taper
|
NA Participants
this data was not collected
|
NA Participants
this data was not collected
|
SECONDARY outcome
Timeframe: week 49Population: Full analysis set
Outcome measures
| Measure |
CFZ533
n=22 Participants
CFZ533 10 mg/kg
|
Placebo
n=22 Participants
Placebo
|
|---|---|---|
|
Number of Patients Who Discontinued Due to Inefficacy or Worsening
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 25Population: PD analysis set, participants with measure
The MG-ADL is an 8-item survey to assess functional performance of daily activities that are sometimes impaired by MG e.g. talking, breathing, swallowing etc. (Muppidi et al 2011). The higher score on MG-ADL scale (0-24 points) indicates worse functional performance of daily activities.
Outcome measures
| Measure |
CFZ533
n=19 Participants
CFZ533 10 mg/kg
|
Placebo
n=18 Participants
Placebo
|
|---|---|---|
|
Mean Change From Baseline in the Myasthenia Gravis-specific Activities of Daily Living Scale (MG-ADL)
|
-2.6 score
Standard Deviation 2.97
|
-1.1 score
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: week 49Population: PD analysis set, participants with measure
QMG (quantitative myasthenia gravis) score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005). A decrease in the QMG score indicated an improvement. Results given as a change in the score as compared from baseline
Outcome measures
| Measure |
CFZ533
n=18 Participants
CFZ533 10 mg/kg
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|
|
Mean Changes From Baseline in the QMG Score at Week 49
|
-2.9 score on a scale
Standard Deviation 5.16
|
-2.6 score on a scale
Standard Deviation 4.30
|
SECONDARY outcome
Timeframe: week 25Population: PD analysis set, participants with measure
The MG-QOL15 is a 15-item survey, completed by MG patients and it is designed to assess some aspects of quality of life (QoL) related to MG (Burns et al 2011) e.g. assesment of mood, eating, speaking, driving a car etc.. The higher score on MG-QOL15 scale (0-60 points) indicates worse QoL.
Outcome measures
| Measure |
CFZ533
n=19 Participants
CFZ533 10 mg/kg
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|
|
Mean Change From Baseline in the Myasthenia Gravis Quality of Life (MG QOL-15)
|
-9.7 score
Standard Deviation 11.0
|
-6.7 score
Standard Deviation 10.86
|
SECONDARY outcome
Timeframe: week 1, week 25Population: Pharmacodynamic analysis set, participants with measure
CD40 receptor occupancy by CFZ533 in peripheral blood was assessed by flow cytometry analysis, measuring free or total CD40 receptors on whole blood B cells. Free CD40 on CD19-positive B cells, using PE-conjugated CFZ533 whose binding was prevented by bound, unconjugated CFZ533 (drug bound to CD40 on peripheral blood B cells). The more CD40 was occupied by unlabeled CFZ533, the less binding of labeled CFZ533, manifest as a lower mean fluorescence intensity (MFI) of CD40 on B cells. MFI from free CD40 on B cells was converted into Molecules of Equivalent Soluble Fluorochrome (MESF) using PE-MESF beads.
Outcome measures
| Measure |
CFZ533
n=22 Participants
CFZ533 10 mg/kg
|
Placebo
n=22 Participants
Placebo
|
|---|---|---|
|
Free CD40 on B Cells
Free CD40 on B cells week 1 predose
|
34242.9 MESF
Standard Deviation 18455.80
|
31025.9 MESF
Standard Deviation 16138.97
|
|
Free CD40 on B Cells
Free CD40 on B cells week 25
|
5259.1 MESF
Standard Deviation 11341.57
|
24908.3 MESF
Standard Deviation 5022.03
|
SECONDARY outcome
Timeframe: week1, week 25Population: pharmacodynamic analysis set, participants with measure
PD
Outcome measures
| Measure |
CFZ533
n=22 Participants
CFZ533 10 mg/kg
|
Placebo
n=22 Participants
Placebo
|
|---|---|---|
|
Total Soluble CD40 (sCD40) in Plasma
week 1
|
0.1778 ng/ml
Standard Deviation 0.13077
|
0.1577 ng/ml
Standard Deviation 0.17243
|
|
Total Soluble CD40 (sCD40) in Plasma
week 25
|
191.1278 ng/ml
Standard Deviation 69.67597
|
0.1163 ng/ml
Standard Deviation 0.18298
|
SECONDARY outcome
Timeframe: week 17Population: pharmacokinetic set, participants treated with CFZ533 only, with measure
Outcome measures
| Measure |
CFZ533
n=18 Participants
CFZ533 10 mg/kg
|
Placebo
Placebo
|
|---|---|---|
|
Plasma CFZ533 Concentration at Steady State Conditions (Week 17)
|
120 micrograms/mL
Standard Deviation 40.5
|
—
|
Adverse Events
CFZ533 10 mg/kg IV Infusion
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo IV Infusion
Serious events: 4 serious events
Other events: 21 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CFZ533 10 mg/kg IV Infusion
n=22 participants at risk
CFZ533 10 mg/kg IV infusion
|
Placebo IV Infusion
n=22 participants at risk
Placebo IV infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Eye disorders
Glaucoma
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
General disorders
Pyrexia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Influenza
|
9.1%
2/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Pneumonia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Myasthenia gravis
|
9.1%
2/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Myasthenia gravis crisis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Radial nerve palsy
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
Other adverse events
| Measure |
CFZ533 10 mg/kg IV Infusion
n=22 participants at risk
CFZ533 10 mg/kg IV infusion
|
Placebo IV Infusion
n=22 participants at risk
Placebo IV infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
2/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.5%
1/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Blood and lymphatic system disorders
Neutrophilia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Cardiac disorders
Palpitations
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Congenital, familial and genetic disorders
Von Willebrand's disease
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Eye disorders
Cataract
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Food poisoning
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Gastroduodenitis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
General disorders
Asthenia
|
0.00%
0/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
General disorders
Chills
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
General disorders
Discomfort
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
General disorders
Fatigue
|
9.1%
2/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
General disorders
Feeling cold
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
General disorders
Hyperthermia
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
General disorders
Influenza like illness
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
General disorders
Infusion site bruising
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
General disorders
Malaise
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
General disorders
Non-cardiac chest pain
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
General disorders
Pyrexia
|
0.00%
0/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Bronchitis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Cystitis
|
4.5%
1/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Infections and infestations
Ear infection
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Folliculitis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Gastrointestinal infection
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Infections and infestations
Influenza
|
4.5%
1/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Laryngitis viral
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
2/22 • up to week 49
AE additional description
|
13.6%
3/22 • up to week 49
AE additional description
|
|
Infections and infestations
Oral candidiasis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Oral herpes
|
4.5%
1/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Pneumonia
|
9.1%
2/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Respiratory tract infection
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Respiratory tract infection viral
|
9.1%
2/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Infections and infestations
Rhinitis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Skin candida
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Systemic infection
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Tooth infection
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Tracheobronchitis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
1/22 • up to week 49
AE additional description
|
18.2%
4/22 • up to week 49
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Infections and infestations
Viral pharyngitis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Investigations
Activated partial thromboplastin time shortened
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Investigations
Blood creatinine increased
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Investigations
Blood pressure increased
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Investigations
C-reactive protein increased
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Investigations
Free haemoglobin present
|
9.1%
2/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Investigations
Prothrombin time prolonged
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Investigations
Weight decreased
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
2/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Dementia Alzheimer's type
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • up to week 49
AE additional description
|
9.1%
2/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • up to week 49
AE additional description
|
13.6%
3/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Migraine
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Myasthenia gravis
|
9.1%
2/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Neuralgia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Paraesthesia
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Psychiatric disorders
Depressed mood
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Psychiatric disorders
Nervousness
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Psychiatric disorders
Sleep disorder
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Renal and urinary disorders
Calculus urinary
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Renal and urinary disorders
Haematuria
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • up to week 49
AE additional description
|
4.5%
1/22 • up to week 49
AE additional description
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
4.5%
1/22 • up to week 49
AE additional description
|
0.00%
0/22 • up to week 49
AE additional description
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER