Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis (NCT NCT02750592)
NCT ID: NCT02750592
Last Updated: 2019-09-09
Results Overview
This table is ASAS20 response using non-responder imputation for FAS It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
week 16
Results posted on
2019-09-09
Participant Flow
A total of 37 patients were screened, and 30 patients (81.1%) completed the screening phase and entered Treatment Period
Seven patients were screening failures
Participant milestones
| Measure |
Secukinumab 150mg
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Secukinumab 150mg
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
Baseline Characteristics
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
|
Age, Customized
<65 years
|
27 Participants
n=5 Participants
|
|
Age, Customized
>=65years
|
3 Participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 16Population: Full analysis set (FAS): The FAS comprised of all patients who entered into the treatment periods.
This table is ASAS20 response using non-responder imputation for FAS It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Assessment of SpondyloArthritis International Society 20 Response (ASAS20)
|
21 participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS 40 response ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
ASAS 40 Response Rate With Non-responder Imputation (NRI)
|
14 participants
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 response The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate
|
11 participants
|
SECONDARY outcome
Timeframe: baseline, Week 16Population: FAS
hsCRP (mg/L) change from baseline using observed data with log e transformation The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline of high sensitivity C-Reactive Protein (hsCRP) hsCRP is measured as a marker of inflammation from blood samples during the study
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Change in High Sensitivity C-Reactive Protein (hsCRP)
|
0.247 mg/L
Interval 0.125 to 0.487
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients meeting the ASAS 5/6 response criteria The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
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|---|---|
|
Number of Participants With ASAS 5/6 Response Criteria
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: FAS
The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in total BASDAI The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS Each question (question 1 to 6) is scored from 0 to 10 (0 being no problem and 10 being the worst problem). To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score.
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Mean Change From Baseline in BASDAI From Baseline
|
-3.088 scores on a scale
Standard Deviation 2.0697
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: FAS
SF-36 PCS, mean change from baseline: The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions Score range is from 0 (no problems) to 100 (unable to perform the activity) SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline. There is no total overall score; scoring is computed for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score.
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score
|
6.306 scores on a scale
Standard Deviation 8.0724
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: FAS
The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity)
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
|
-3.40 scores on a scale
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: week 16Population: FAS
The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS partial remission The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Proportion of Participants Achieving ASAS Partial Remission
|
6 participants
20.0
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, 16, 24, 52, 60Population: FAS
The assessment of pre dose concentration of secukinumab in Japanese AS patients An enzyme-linked immunosorbent assay (ELISA) method will be used for bioanalytical analysis of secukinumab in serum, with an anticipated lower limit of quantification (LLOQ) of 80 ng/mL.
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Change in Serum Concentration of Secukinumab
week 16
|
25.0 μg/mL
Standard Deviation 10.19
|
|
Change in Serum Concentration of Secukinumab
week 24
|
22.2 μg/mL
Standard Deviation 8.96
|
|
Change in Serum Concentration of Secukinumab
week 52
|
21.1 μg/mL
Standard Deviation 6.08
|
|
Change in Serum Concentration of Secukinumab
week 60
|
6.2 μg/mL
Standard Deviation 3.61
|
|
Change in Serum Concentration of Secukinumab
week 4
|
51.3 μg/mL
Standard Deviation 15.35
|
SECONDARY outcome
Timeframe: week 60Population: The safety set included all patients who took at least one dose of study treatment during the treatment periods.
Concentration of anti-secukinumab antibodies Assessment of immunogenicity against secukinumab by concentration of anti-secukinumab antibodies at pre-dose. An electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation.
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Number of Participants With Immunogenicity Against Secukinumab
|
0 participants
|
SECONDARY outcome
Timeframe: week 60Population: The safety set included all patients who took at least one dose of study treatment during the treatment periods.
Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. \*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. \*\*Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Hemoglobin (g/L) <LLN - 100 g/L (Grade1)
|
6 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Hemoglobin (g/L) <100 - 80 g/L (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Hemoglobin (g/L) < 80g/L (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Lymphocytes (10E9/L) <LLN - 0.8 × 10e9/L (Grade1)
|
2 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Lymphocytes (10E9/L) <0.8 - 0.5 × 10e9/L (Grade2)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Lymphocytes (10E9/L) <0.5 - 0.2 × 10e9/L (Grade3)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Lymphocytes (10E9/L) <0.2 × 10e9/L (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Neutrophils (10E9/L) < LLN - 1.5 × 10e9/L (Grade1)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Neutrophils (10E9/L) < 1.5 - 1.0 × 10e9/L (Grade2)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Neutrophils (10E9/L) < 1.0 - 0.5 × 10e9/L (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Neutrophils (10E9/L) < 0.5 × 10e9/L (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Platelets (10E9/L) <LLN - 75.0 ×10e9/L (Grade1)
|
3 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Platelets (10E9/L) <75.0 - 50.0 ×10e9/L (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Platelets (10E9/L) <50.0 - 25.0 ×10e9/L (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Platelets (10E9/L), Blood <25.0 ×10e9/L (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Leukocytes (10E9/L) <LLN - 3.0 × 10e9/L (Grade1)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Leukocytes (10E9/L) <3.0 - 2.0 × 10e9/L (Grade2)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Leukocytes (10E9/L) <2.0 - 1.0 × 10e9/L (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
Leukocytes (10E9/L) <1.0 × 10e9/L (Grade4)
|
0 participants
|
SECONDARY outcome
Timeframe: week 60Population: safety set
Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. \*Instrumental ADL include preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. \*\*Self care ADL include bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Cholesterol (mmol/L), Serum (Grade1) Serum
|
4 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alkaline Phosphatase (U/L), Serum (Grade1)
|
3 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alkaline Phosphatase (U/L), Serum (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alkaline Phosphatase (U/L), Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alkaline Phosphatase (U/L), Serum (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alanine Aminotransferase (U/L), Serum (Grade1)
|
3 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alanine Aminotransferase (U/L), Serum (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alanine Aminotransferase (U/L), Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Alanine Aminotransferase (U/L), Serum (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Aspartate Aminotransferase (U/L), Serum (Grade1)
|
4 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Aspartate Aminotransferase (U/L), Serum (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Aspartate Aminotransferase (U/L), Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Aspartate Aminotransferase (U/L), Serum (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Bilirubin (umol/L), Serum (Grade1)
|
2 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Bilirubin (umol/L), Serum (Grade2)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Bilirubin (umol/L), Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Bilirubin (umol/L), Serum (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Cholesterol (mmol/L), Serum (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Cholesterol (mmol/L), Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Cholesterol (mmol/L), Serum (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Creatinine (umol/L), Plasma/Serum (Grade1)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Creatinine (umol/L), Plasma/Serum (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Creatinine (umol/L), Plasma/Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Creatinine (umol/L), Plasma/Serum (Grade4) Serum
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Gamma Glutamyl Transferase (U/L), Serum (Grade1)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Gamma Glutamyl Transferase (U/L), Serum (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Gamma Glutamyl Transferase (U/L), Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Gamma Glutamyl Transferase (U/L), Serum (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Decreased (mmol/L), Plasma (Grade1)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Decreased (mmol/L), Plasma (Grade2)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Decreased (mmol/L), Plasma (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Decreased (mmol/L), Plasma (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Increased (mmol/L), Plasma (Grade1)
|
12 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Increased (mmol/L), Plasma (Grade2)
|
3 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Increased (mmol/L), Plasma (Grade3)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Glucose Increased (mmol/L), Plasma (Grade4)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Triglycerides (mmol/L), Plasma/Serum (Grade1)
|
9 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Triglycerides (mmol/L), Plasma/Serum (Grade2)
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Triglycerides (mmol/L), Plasma/Serum (Grade3)
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
Triglycerides (mmol/L), Plasma/Serum (Grade4)
|
0 participants
|
SECONDARY outcome
Timeframe: week 60Population: safety set
During the entire safety reporting period, mean values of each liver enzyme parameter stayed within the normal range and were comparable to the baseline values ALP=Alkaline phosphatase ALT=Alanine aminotransferase AST=Aspartate aminotransferase TBL=Total bilirubin ULN=Upper Limit Normal
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
AST > 8 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
AST > 10 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 5 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 8 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
TBL > 3 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT > 3 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT > 5 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT > 8 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT > 10 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT > 20 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
AST > 3 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
AST > 5 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
AST > 20 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 3 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 10 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 20 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
TBL > 1.5 × ULN
|
1 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
TBL > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALP > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALP > 3 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALP > 5 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 3 × ULN & TBL > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 5 × ULN & TBL > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 8 × ULN & TBL > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST > 10 × ULN & TBL > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALP > 3 × ULN & TBL > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALP > 5 × ULN & TBL > 2 × ULN
|
0 participants
|
|
Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
ALT or AST> 3 × ULN & TBL> 2 × ULN & ALP <2 × ULN
|
0 participants
|
SECONDARY outcome
Timeframe: week 60Population: safety set
During the entire safety reporting period, mean values of each lipid parameter stayed within the normal range and were comparable to the baseline values
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
HDL: ≤ LLN
|
5 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
HDL: < 0.8 × LLN
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
LDL: ≥ ULN
|
1 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
LDL: > 1.5 × ULN
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
LDL: > 2.5 × ULN
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
Cholesterol: ≥ ULN
|
4 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
Cholesterol: > 1.5 × ULN
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
Cholesterol: > 2.5 × ULN
|
0 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
Triglycerides: ≥ ULN
|
8 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
Triglycerides: > 1.5 × ULN
|
4 participants
|
|
Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
Triglycerides: > 2.5 × ULN
|
0 participants
|
SECONDARY outcome
Timeframe: week 60Population: safety set
Sitting Pulse (bpm) High only (\> 100 bpm) Low only (\< 60 bpm) Low and High (\< 60 bpm and \> 100 bpm) Sitting Diastolic Blood Pressure (BP) (mmHg) High only (≥ 90 mmHg) Low only (\< 60 mmHg) Low and High (\< 60 mmHg and ≥ 90 mmHg) Sitting Systolic Blood Pressure (mmHg) High only (≥ 140 mmHg) Low only (\< 90 mmHg) Low and High (\< 90 mmHg and ≥ 140 mmHg)
Outcome measures
| Measure |
Secukinumab 150mg
n=30 Participants
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Pulse (bpm) High only
|
2 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Pulse (bpm) Low only
|
5 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Pulse (bpm) Low and High
|
0 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Diastolic BP (mmHg), High only
|
8 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Diastolic BP (mmHg), Low only
|
5 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Diastolic BP (mmHg), Low and high
|
0 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Systolic BP (mmHg) High only
|
12 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Systolic BP (mmHg) Low only
|
0 participants
|
|
Participants With Newly Occurring Notable Abnormalities in Vital Signs
Sitting Systolic BP (mmHg) Low and High
|
0 participants
|
Adverse Events
AIN457 150mg
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 150mg
n=30 participants at risk
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Cardiac disorders
Coronary artery occlusion
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
3.3%
1/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
Other adverse events
| Measure |
AIN457 150mg
n=30 participants at risk
A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
23.3%
7/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
General disorders
Pyrexia
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Infections and infestations
Bronchitis
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Infections and infestations
Gastroenteritis
|
10.0%
3/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Infections and infestations
Infected dermal cyst
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Infections and infestations
Influenza
|
16.7%
5/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
15/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Infections and infestations
Pharyngitis
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
|
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