Trial Outcomes & Findings for Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS). (NCT NCT01242813)
NCT ID: NCT01242813
Last Updated: 2016-02-04
Results Overview
Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (\<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than \[≥\] 70% reduction of baseline CRP and/or SAA).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Day 15
Results posted on
2016-02-04
Participant Flow
The study was conducted at 6 centers in 3 countries.
A total of 29 participants were screened, out of which 20 were enrolled and exposed to study medication. Nine participants were considered as screening failures due to unacceptable laboratory value or test procedure results.
Participant milestones
| Measure |
Canakinumab
Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (\>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Canakinumab
Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (\>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
Baseline characteristics by cohort
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Age, Continuous
|
34.62 Years
STANDARD_DEVIATION 18.362 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy.
Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (\<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than \[≥\] 70% reduction of baseline CRP and/or SAA).
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants With Complete or Almost Complete Response at Day 15
|
95 Percentage of participants
Interval 75.1 to 99.9
|
SECONDARY outcome
Timeframe: Day 8Population: The analysis was performed on the FAS population.
Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as CRP and/or SAA \< 10 mg/L. Almost complete response was defined as clinical remission and a partial serological remission (≥70% reduction of baseline CRP and/or SAA).
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants With Complete or Almost Complete Response at Day 8
|
80 Percentage of participants
Interval 56.3 to 94.3
|
SECONDARY outcome
Timeframe: Day 8 and Day 15Population: The analysis was performed on the FAS population.
Complete clinical remission was defined as Physician's Global Assessment of TRAPS activity to be absent or minimal (1). TRAPS associated clinical signs and symptoms were assessed by the investigator at every visit on a 5-point scale: 0 = Absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants With Complete Clinical Remission at Day 8 and 15
Day 8
|
90 Percentage of participants
Interval 68.3 to 98.8
|
|
Percentage of Participants With Complete Clinical Remission at Day 8 and 15
Day 15
|
100 Percentage of participants
Interval 83.2 to 100.0
|
SECONDARY outcome
Timeframe: Day 8 and Day 15Population: The analysis was performed on the FAS population.
The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15
Day 8
|
35 Percentage of participants
Interval 15.4 to 59.2
|
|
Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15
Day 15
|
60 Percentage of participants
Interval 36.1 to 80.9
|
SECONDARY outcome
Timeframe: Baseline up to Day 15Population: The analysis was performed on the FAS population.
Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a Physician's Global Assessment of TRAPS symptoms of scale 1 or less. The physician's Global Assessment was based on a 5-point scale: 0 = None/absent ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Time to Physician's Assessed Clinical Remission
|
4 Days
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 15Population: The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Participants who had not achieved a complete response at Day 8 were given an additional dose of canakinumab. Complete response was defined as clinical remission (Physician's Global Assessment of TRAPS activity absent or minimal) and serological remission (CRP and/or SAA \< 10 mg/L). Almost complete response was defined as clinical remission and a partial serological remission (≥ 70% reduction of baseline CRP and/or SAA).
Outcome measures
| Measure |
Canakinumab
n=4 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8
|
100 Percentage of participants
Interval 39.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 15Population: The analysis was performed on the FAS population.
Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a participant's Global Assessment of TRAPS symptoms of scale 1 or less. The participant's Global Assessment was based on a 5-point scale: 0 = None/absent (no) ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Time to Participant's Assessed Clinical Remission
|
3 Days
Interval 1.0 to 11.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 953 (End of study)Population: The analysis was performed on the FAS population.
The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. Negative percent change in concentration of inflammatory markers indicated improvement.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study
CRP
|
-92.19 Percent change
Interval -99.0 to 43.6
|
|
Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study
SAA
|
-96.54 Percent change
Interval -99.8 to 68.3
|
SECONDARY outcome
Timeframe: Day 113 (end of treatment period) up to Day 925 (End of study)Population: The analysis was performed on the FAS population.
TRAPS signs and symptoms were assessed in 4 key categories: skin disease (skin rash), eye manifestations, extremity pain (musculoskeletal), and abdominal pain. Participants were assessed for TRAPS associated signs and symptoms a 5-point Physician's global assessment scale: None/absent (no); 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Skin rash moderate
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Extremity pain mild
|
5 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Extremity pain moderate
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Abdominal pain severe
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Skin rash absent
|
95 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Skin rash minimal
|
5 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Skin rash mild
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Skin rash severe
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Eye manifestations absent
|
90 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Eye manifestations minimal
|
10 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Eye manifestations mild
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Eye manifestations moderate
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Eye manifestations severe
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Extremity pain absent
|
90 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Extremity pain minimal
|
5 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Extremity pain severe
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Abdominal pain absent
|
95 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Abdominal pain minimal
|
5 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Abdominal pain mild
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain
Abdominal pain moderate
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 953 (End of study)Population: The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Participants were assessed based by physician on Physician's Global Assessment measured on a 5-point scale for TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Outcome measures
| Measure |
Canakinumab
n=18 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants With Defined Grades in Physician's Global Assessment Score
None
|
84.2 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Physician's Global Assessment Score
Minimal
|
10.5 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Physician's Global Assessment Score
Mild
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Physician's Global Assessment Score
Moderate
|
0 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Physician's Global Assessment Score
Severe
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 253 (End of follow-up period)Population: The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.
Outcome measures
| Measure |
Canakinumab
n=12 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants With Defined Grades in Participant's Global Assessment Score
Absent
|
41.7 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Participant's Global Assessment Score
Minimal
|
33.3 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Participant's Global Assessment Score
Mild
|
8.3 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Participant's Global Assessment Score
Moderate
|
16.7 Percentage of participants
|
|
Percentage of Participants With Defined Grades in Participant's Global Assessment Score
Severe
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953Population: The analysis was performed on the FAS population.
Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Relapsed Participants
Day 421
|
5 Percentage of participants
Interval 0.1 to 27.3
|
|
Percentage of Relapsed Participants
Day 449
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 757
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 785
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 813
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 15
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 29
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 57
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 85
|
5 Percentage of participants
Interval 0.1 to 24.9
|
|
Percentage of Relapsed Participants
Day 113
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable..
|
|
Percentage of Relapsed Participants
Day 141
|
10 Percentage of participants
Interval 1.3 to 33.1
|
|
Percentage of Relapsed Participants
Day 169
|
10 Percentage of participants
Interval 1.9 to 45.5
|
|
Percentage of Relapsed Participants
Day 197
|
35 Percentage of participants
Interval 30.8 to 89.1
|
|
Percentage of Relapsed Participants
Day 225
|
10 Percentage of participants
Interval 6.8 to 93.2
|
|
Percentage of Relapsed Participants
Day 253
|
10 Percentage of participants
Interval 1.2 to 31.7
|
|
Percentage of Relapsed Participants
Day 281
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 309
|
10 Percentage of participants
Interval 1.2 to 31.7
|
|
Percentage of Relapsed Participants
Day 337
|
5 Percentage of participants
Interval 0.1 to 24.9
|
|
Percentage of Relapsed Participants
Day 365
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 393
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 477
|
5 Percentage of participants
Interval 0.1 to 26.0
|
|
Percentage of Relapsed Participants
Day 505
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 533
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 561
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 589
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 617
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 645
|
5 Percentage of participants
Interval 0.5 to 71.6
|
|
Percentage of Relapsed Participants
Day 673
|
15 Percentage of participants
Interval 3.6 to 41.4
|
|
Percentage of Relapsed Participants
Day 701
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 729
|
5 Percentage of participants
Interval 0.1 to 27.3
|
|
Percentage of Relapsed Participants
Day 841
|
10 Percentage of participants
Interval 1.4 to 34.7
|
|
Percentage of Relapsed Participants
Day 869
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
Day 897
|
10 Percentage of participants
Interval 1.4 to 34.7
|
|
Percentage of Relapsed Participants
Day 925
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
|
Percentage of Relapsed Participants
End of Study (Day 953)
|
0 Percentage of participants
As no participant relapsed at the specified time-points, the confidence Interval value was not applicable.
|
SECONDARY outcome
Timeframe: Day 85 to Day 253 (End of treatment period to Follow-up period)Population: The analysis was performed on the FAS population.
Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Time to Relapse After Last Dose of Canakinumab
|
91.5 Days
Interval 65.0 to 117.0
|
SECONDARY outcome
Timeframe: Day 85 to Day 953 (End of treatment period to End of study)Population: The analysis was performed on the FAS population.
Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Percentage of Participants Who Relapsed and Received Rescue Medication
Corticosteroid
|
25 Percentage of participants
Interval 8.7 to 49.1
|
|
Percentage of Participants Who Relapsed and Received Rescue Medication
NSAID
|
25 Percentage of participants
Interval 8.7 to 49.1
|
|
Percentage of Participants Who Relapsed and Received Rescue Medication
Both corticosteroid and NSAID
|
10 Percentage of participants
Interval 1.2 to 31.7
|
SECONDARY outcome
Timeframe: Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953Population: The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Serum Concentration of Canakinumab
Day 3 (n=20)
|
12.737 microgram(s)/milliliter
Standard Deviation 5.3158
|
|
Serum Concentration of Canakinumab
Day 8 (n=19)
|
13.874 microgram(s)/milliliter
Standard Deviation 4.5851
|
|
Serum Concentration of Canakinumab
Day 15 (n=19)
|
13.609 microgram(s)/milliliter
Standard Deviation 5.5868
|
|
Serum Concentration of Canakinumab
Day 29 (n=20)
|
9.911 microgram(s)/milliliter
Standard Deviation 4.2272
|
|
Serum Concentration of Canakinumab
Day 57 (n=20)
|
13.605 microgram(s)/milliliter
Standard Deviation 5.4975
|
|
Serum Concentration of Canakinumab
Day 85 (n=20)
|
15.291 microgram(s)/milliliter
Standard Deviation 6.4353
|
|
Serum Concentration of Canakinumab
Day 113 (n=20)
|
15.837 microgram(s)/milliliter
Standard Deviation 6.828
|
|
Serum Concentration of Canakinumab
Day 141 (n=17)
|
8.799 microgram(s)/milliliter
Standard Deviation 3.1486
|
|
Serum Concentration of Canakinumab
Day 169 (n=12)
|
5.655 microgram(s)/milliliter
Standard Deviation 2.2158
|
|
Serum Concentration of Canakinumab
Day 197 (n=8)
|
3.906 microgram(s)/milliliter
Standard Deviation 1.6446
|
|
Serum Concentration of Canakinumab
Day 225 (n=2)
|
2.725 microgram(s)/milliliter
Standard Deviation 1.2799
|
|
Serum Concentration of Canakinumab
Day 253 (n=9)
|
10.261 microgram(s)/milliliter
Standard Deviation 7.9592
|
|
Serum Concentration of Canakinumab
Day 281 (n=20)
|
9.759 microgram(s)/milliliter
Standard Deviation 4.6194
|
|
Serum Concentration of Canakinumab
Day 309 (n=13)
|
13.088 microgram(s)/milliliter
Standard Deviation 4.6648
|
|
Serum Concentration of Canakinumab
Day 337 (n=11)
|
13.182 microgram(s)/milliliter
Standard Deviation 5.464
|
|
Serum Concentration of Canakinumab
Day 365 (n=9)
|
15.531 microgram(s)/milliliter
Standard Deviation 6.7944
|
|
Serum Concentration of Canakinumab
Day 393 (n=2)
|
20.95 microgram(s)/milliliter
Standard Deviation 1.6263
|
|
Serum Concentration of Canakinumab
Day 421 (n=2)
|
20.9 microgram(s)/milliliter
Standard Deviation 2.9698
|
|
Serum Concentration of Canakinumab
Day 449 (n=17)
|
17.319 microgram(s)/milliliter
Standard Deviation 6.496
|
|
Serum Concentration of Canakinumab
Day 533 (n=1)
|
18.4 microgram(s)/milliliter
Standard Deviation NA
As there was only 1 participant analyzed at the specified time-points, so the standard deviation value was not applicable.
|
|
Serum Concentration of Canakinumab
Day 561 (n=4)
|
15.55 microgram(s)/milliliter
Standard Deviation 2.2128
|
|
Serum Concentration of Canakinumab
Day 589 (n=5)
|
16.48 microgram(s)/milliliter
Standard Deviation 3.8134
|
|
Serum Concentration of Canakinumab
Day 617 (n=17)
|
14.124 microgram(s)/milliliter
Standard Deviation 5.8931
|
|
Serum Concentration of Canakinumab
Day 645 (n=1)
|
7.45 microgram(s)/milliliter
Standard Deviation NA
As there was only 1 participant analyzed at the specified time-points, so the standard deviation value was not applicable.
|
|
Serum Concentration of Canakinumab
Day 673 (n=5)
|
9.802 microgram(s)/milliliter
Standard Deviation 4.6757
|
|
Serum Concentration of Canakinumab
Day 729 (n=5)
|
8.912 microgram(s)/milliliter
Standard Deviation 3.4413
|
|
Serum Concentration of Canakinumab
Day 785 (n=18)
|
7.757 microgram(s)/milliliter
Standard Deviation 2.2948
|
|
Serum Concentration of Canakinumab
Day 841 (n=4)
|
8.528 microgram(s)/milliliter
Standard Deviation 2.112
|
|
Serum Concentration of Canakinumab
Day 897 (n=9)
|
8.157 microgram(s)/milliliter
Standard Deviation 2.6782
|
|
Serum Concentration of Canakinumab
Day 925 (n=3)
|
10.527 microgram(s)/milliliter
Standard Deviation 7.4405
|
|
Serum Concentration of Canakinumab
Day 953 (n=10)
|
9.56 microgram(s)/milliliter
Standard Deviation 2.9375
|
SECONDARY outcome
Timeframe: Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953Population: The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL).
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 561 (n=4)
|
15.008 pg/mL
Standard Deviation 5.4952
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 3 (n=20)
|
12.616 pg/mL
Standard Deviation 20.441
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 8 (n=19)
|
16.811 pg/mL
Standard Deviation 20.237
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 15 (n=19)
|
10.662 pg/mL
Standard Deviation 7.6915
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 29 (n=20)
|
9.342 pg/mL
Standard Deviation 5.1266
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 57 (n=20)
|
10.701 pg/mL
Standard Deviation 4.5329
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 85 (n=20)
|
11.212 pg/mL
Standard Deviation 4.1552
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 113 (n=20)
|
14.401 pg/mL
Standard Deviation 5.491
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 141 (n=17)
|
10.779 pg/mL
Standard Deviation 4.1092
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 169 (n=12)
|
10.912 pg/mL
Standard Deviation 8.2431
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 197 (n=8)
|
30.098 pg/mL
Standard Deviation 41.158
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 225 (n=2)
|
3.52 pg/mL
Standard Deviation 0.9475
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 253 (n=9)
|
25.002 pg/mL
Standard Deviation 28.274
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 281 (n=20)
|
13.722 pg/mL
Standard Deviation 7.5574
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 309 (n=13)
|
22.478 pg/mL
Standard Deviation 16.688
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 337 (n=11)
|
19.904 pg/mL
Standard Deviation 10.789
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 365 (n=9)
|
16.338 pg/mL
Standard Deviation 5.8318
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 393 (n=2)
|
27.6 pg/mL
Standard Deviation 10.182
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 421 (n=2)
|
30.65 pg/mL
Standard Deviation 12.94
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 449 (n=17)
|
17.723 pg/mL
Standard Deviation 8.8367
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 533 (n=1)
|
25.2 pg/mL
Standard Deviation NA
As there was only 1 participant analyzed at the specified time-points, so the standard deviation value was not applicable.
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 589 (n=5)
|
16.99 pg/mL
Standard Deviation 5.2212
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 617 (n=17)
|
14.34 pg/mL
Standard Deviation 6.1663
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 645 (n=1)
|
16 pg/mL
Standard Deviation NA
As there was only 1 participant analyzed at the specified time-points, so the standard deviation value was not applicable.
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 673 (n=5)
|
15.296 pg/mL
Standard Deviation 11.908
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 729 (n=5)
|
16.702 pg/mL
Standard Deviation 12.386
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 785 (n=18)
|
12.698 pg/mL
Standard Deviation 6.0688
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 841 (n=4)
|
12.478 pg/mL
Standard Deviation 6.9548
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 897 (n=9)
|
12.331 pg/mL
Standard Deviation 8.032
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 925 (n=3)
|
15.033 pg/mL
Standard Deviation 1.7502
|
|
Serum Concentration of Total Interleukin-1β Antibody (IL-1β)
Day 953 (n=10)
|
11.701 pg/mL
Standard Deviation 7.9172
|
SECONDARY outcome
Timeframe: Day 1 up to Day 953 (End of study)Population: The analysis was performed on the FAS population.
Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.
Outcome measures
| Measure |
Canakinumab
n=20 Participants
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Number of Participants With Anti-canakinumab Antibodies at Any Visit
|
2 Number of participants
|
Adverse Events
Canakinumab
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Canakinumab
n=20 participants at risk
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Cardiac disorders
Pericarditis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Condition aggravated
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
Other adverse events
| Measure |
Canakinumab
n=20 participants at risk
Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants \> 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Deafness
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Ear pain
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Chalazion
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Conjunctivitis allergic
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Eye pain
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Eye pruritus
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Eye swelling
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Eyelid oedema
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Ocular hyperaemia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Eye disorders
Periorbital oedema
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
55.0%
11/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
4/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dental caries
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
8/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Haematochezia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
7/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Asthenia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Chest pain
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Condition aggravated
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Fatigue
|
35.0%
7/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
50.0%
10/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Immune system disorders
Seasonal allergy
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
20.0%
4/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Cystitis
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Ear infection
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Enterobiasis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Fungal skin infection
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Gingivitis
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Haemorrhoid infection
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Influenza
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Laryngitis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
60.0%
12/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Onychomycosis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Oral candidiasis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Pharyngitis
|
20.0%
4/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Pharyngotonsillitis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Respiratory tract infection
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Rhinitis
|
25.0%
5/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Tinea infection
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Tonsillitis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Tooth abscess
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Tooth infection
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
30.0%
6/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection viral
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Viral infection
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Investigations
Blood iron decreased
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Investigations
Blood triglycerides increased
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Investigations
Occult blood positive
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.0%
8/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
30.0%
6/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.0%
6/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
55.0%
11/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Sinus headache
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Polyuria
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Strangury
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Breast cyst
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Breast mass
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
6/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
55.0%
11/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Nasal septal operation
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Tooth extraction
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
|
Vascular disorders
Phlebitis
|
5.0%
1/20 • Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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