Study of Efficacy and Safety of Secukinumab in Subjects W... | NCT03066609 | Trialant
NCT03066609
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Dec 30, 2019Actual
Enrollment
543Actual
Phase
Phase 3
Conditions
Plaque Psoriasis
Interventions
Secukinumab 150 mg s.c.
Secukinumab 300 mg s.c.
Placebo
Countries
China
Hungary
Malaysia
Philippines
Thailand
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT03066609
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CAIN457A2318
Secondary IDs
Not provided
Brief Title
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Official Title
A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Twelve Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis With or Without Psoriatic Arthritis Comorbidity
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Dec 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 28, 2017Actual
Primary Completion Date
Dec 21, 2017Actual
Completion Date
Nov 20, 2018Actual
First Submitted Date
Feb 22, 2017
First Submission Date that Met QC Criteria
Feb 22, 2017
First Posted Date
Feb 28, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 14, 2019
Results First Submitted that Met QC Criteria
Dec 9, 2019
Results First Posted Date
Dec 30, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 9, 2019
Last Update Posted Date
Dec 30, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis
Detailed Description
Not provided
Conditions Module
Conditions
Plaque Psoriasis
Keywords
Plaque psoriasis
Secukinumab
Skin condition
skin disease
itching
psoriasis vulgaris
immune-mediated systemic disease
skin lesions
scaly patches
papules
psoriasis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
543Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Secukinumab 150mg
Experimental
Secukinumab 150mg s.c.
Drug: Secukinumab 150 mg s.c.
Secukinumab 300mg
Experimental
Secukinumab 300mg s.c.
Drug: Secukinumab 300 mg s.c.
Placebo
Placebo Comparator
Placebo to secukinumab s.c
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Secukinumab 150 mg s.c.
Drug
150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
Secukinumab 150mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Week 12
Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects must give a written, signed and dated informed consent.
Men or women at least 18 years of age at time of screening.
Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
Moderate to severe psoriasis as defined at Baseline by:
PASI score of 12 or greater, and
IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
topical treatment and/or,
phototherapy and/or,
previous systemic therapy.
Exclusion Criteria:
Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
Drug-induced psoriasis.
Ongoing use of prohibited treatments.
Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Cai L, Zhang JZ, Yao X, Gu J, Liu QZ, Zheng M, Zhang SF, Xu JH, Li CX, Cheng H, Guo Q, Pan WL, Li SQ, Li RY, Guo ZP, Song ZQ, Li SS, Dong XQ, Wang L, Fu R, Regnault P, Charef P, Mazur R, Patekar M. Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis. Chin Med J (Engl). 2020 Nov 20;133(22):2665-2673. doi: 10.1097/CM9.0000000000001163.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
A total of 664 patients were screened and 543 patients were randomized to one of three treatment groups in the induction period: secukinumab 300 mg (n=272), secukinumab 150 mg (n=136), and placebo (n=135)
300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
Secukinumab 300mg
Placebo
Drug
Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48
Placebo
Week 12
Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Week 52
Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
Week 52
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response
week 1, week 12, week 24, week 52
American Collage of Rheumatology (ACR) Response 20/50/70
Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity
week 12, week 24, week 52
Time to PASI 75 Response up to Week 12
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
full analysis set
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
OG002
Placebo
Placebo
Units
Counts
Participants
OG000136
OG001272
OG002135
Title
Denominators
Categories
Title
Measurements
OG000112
OG001254
OG0026
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
PASI 75
Regression, Logistic
<0.0001
Odds Ratio (OR)
153.94
2-Sided
95
54.02
438.67
Superiority
OG001
OG002
PASI 75
Regression, Logistic
Primary
Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
full analysis set
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
OG002
Placebo
Placebo
Units
Secondary
Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
full analysis set
Posted
Count of Participants
Participants
Week 12
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
OG002
Placebo
Placebo
Secondary
Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
full analysis set with measure
Posted
Count of Participants
Participants
Week 52
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
Units
Counts
Participants
Secondary
Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.
full analysis set with measure
Posted
Count of Participants
Participants
Week 52
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
Units
Counts
Participants
Secondary
PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)
Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response
full analysis set
Posted
Count of Participants
Participants
week 1, week 12, week 24, week 52
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
OG002
Placebo
Placebo
OG003
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
Units
Counts
Participants
Secondary
American Collage of Rheumatology (ACR) Response 20/50/70
Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity
full analysis set
Posted
Count of Participants
Participants
week 12, week 24, week 52
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
OG002
Placebo
Placebo
OG003
Placebo - AIN457 300 mg
patients switched to AIN457 at week 12
Secondary
Time to PASI 75 Response up to Week 12
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
full analysis set
Posted
Median
95% Confidence Interval
days
week 12
ID
Title
Description
OG000
Secukinumab 150mg
Secukinumab 150mg s.c.
OG001
Secukinumab 300mg
Secukinumab 300mg s.c.
Units
Counts
Participants
Time Frame
12 months
Description
Adverse Events and deaths occurring in this on-treatment period plus follow up (+30 days or +5 half- lives) are reported in the Adverse Event Information Tables.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
AIN457 150 mg
AIN457 150 mg
0
136
5
136
115
136
EG001
AIN457 300 mg
AIN457 300 mg
0
272
9
272
221
272
EG002
Any AIN457 300 mg
Any AIN457 300 mg
0
401
14
401
312
401
EG003
Any AIN457 Dose
Any AIN457 dose
0
537
19
537
427
537
EG004
Placebo
Placebo
0
135
2
135
71
135
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina unstable
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG0031 affected537 at risk
EG0040 affected135 at risk
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Hepatic mass
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0012 affected272 at risk
EG0022 affected401 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG003
Comminuted fracture
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Glomerulonephritis chronic
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0011 affected272 at risk
EG0021 affected401 at risk
EG003
Erythrodermic psoriasis
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0020 affected401 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Diabetic vascular disorder
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0010 affected272 at risk
EG0021 affected401 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG00013 affected136 at risk
EG00131 affected272 at risk
EG00242 affected401 at risk
EG00355 affected537 at risk
EG00412 affected135 at risk
Pyrexia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0004 affected136 at risk
EG00114 affected272 at risk
EG00218 affected401 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0009 affected136 at risk
EG00118 affected272 at risk
EG00222 affected401 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0006 affected136 at risk
EG00118 affected272 at risk
EG00226 affected401 at risk
EG003
Influenza
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG00017 affected136 at risk
EG00128 affected272 at risk
EG00238 affected401 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG00015 affected136 at risk
EG00144 affected272 at risk
EG00257 affected401 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG00014 affected136 at risk
EG00124 affected272 at risk
EG00235 affected401 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0002 affected136 at risk
EG00114 affected272 at risk
EG00216 affected401 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0005 affected136 at risk
EG00120 affected272 at risk
EG00225 affected401 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0005 affected136 at risk
EG00114 affected272 at risk
EG00216 affected401 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG00041 affected136 at risk
EG00167 affected272 at risk
EG00297 affected401 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0004 affected136 at risk
EG0014 affected272 at risk
EG0026 affected401 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0007 affected136 at risk
EG00111 affected272 at risk
EG00213 affected401 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0002 affected136 at risk
EG00110 affected272 at risk
EG00212 affected401 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected136 at risk
EG0012 affected272 at risk
EG0022 affected401 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG00011 affected136 at risk
EG00122 affected272 at risk
EG00223 affected401 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG00025 affected136 at risk
EG00156 affected272 at risk
EG00276 affected401 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0004 affected136 at risk
EG00111 affected272 at risk
EG00212 affected401 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0004 affected136 at risk
EG00110 affected272 at risk
EG00210 affected401 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG00013 affected136 at risk
EG00117 affected272 at risk
EG00225 affected401 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG00016 affected136 at risk
EG00125 affected272 at risk
EG00232 affected401 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG00010 affected136 at risk
EG00120 affected272 at risk
EG00225 affected401 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG00012 affected136 at risk
EG00132 affected272 at risk
EG00236 affected401 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0006 affected136 at risk
EG0013 affected272 at risk
EG0023 affected401 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG00012 affected136 at risk
EG00124 affected272 at risk
EG00230 affected401 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0005 affected136 at risk
EG00119 affected272 at risk
EG00222 affected401 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.