Trial Outcomes & Findings for An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis (NCT NCT02557308)
NCT ID: NCT02557308
Last Updated: 2024-12-09
Results Overview
* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction
Recruitment status
TERMINATED
Target enrollment
329 participants
Primary outcome timeframe
Duration of study participation (up to 5 years)
Results posted on
2024-12-09
Participant Flow
Participant flow was summarized by all analysis groups as prespecified in Statistical Analysis Plan.
A total of 350 patients were screened, and 329 patients were enrolled.
Participant milestones
| Measure |
Remsima
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
Patients who switched to Remsima from biologic treatment other than Remicade will be included in this analysis group.
|
Remicade
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
124
|
23
|
10
|
3
|
5
|
0
|
146
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
124
|
23
|
10
|
3
|
5
|
0
|
146
|
17
|
Reasons for withdrawal
| Measure |
Remsima
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
Patients who switched to Remsima from biologic treatment other than Remicade will be included in this analysis group.
|
Remicade
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
3
|
2
|
0
|
1
|
0
|
10
|
1
|
|
Overall Study
Disease Progression
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
4
|
1
|
2
|
0
|
0
|
0
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Close
|
98
|
18
|
5
|
3
|
1
|
0
|
123
|
5
|
|
Overall Study
Except for study close
|
5
|
0
|
0
|
0
|
3
|
0
|
6
|
10
|
Baseline Characteristics
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Remsima
n=124 Participants
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=23 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=10 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=3 Participants
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
n=5 Participants
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group.
|
Other Anti-TNF Drugs
n=146 Participants
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=18 Participants
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group
|
Total
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
n=5 Participants
|
42.0 years
n=7 Participants
|
46.0 years
n=5 Participants
|
32.0 years
n=4 Participants
|
41.0 years
n=21 Participants
|
—
|
38 years
n=115 Participants
|
39 years
n=6 Participants
|
38.0 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
66 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
120 Participants
n=115 Participants
|
13 Participants
n=6 Participants
|
263 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
97 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
129 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
268 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
10 Participants
n=6 Participants
|
61 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Duration of study participation (up to 5 years)Population: All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade II" groups.
* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction
Outcome measures
| Measure |
Remsima
n=124 Participants
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=23 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=10 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=3 Participants
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
n=5 Participants
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group
|
Other Anti-TNF
n=146 Participants
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=18 Participants
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Infusion related reaction/hypersensitivity/ anaphylactic reaction
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of congestive heart failure
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Opportunistic infections (excluding tuberculosis)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Serious infections including sepsis (excluding opportunistic infections and tuberculosis)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of tuberculosis
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Haematological reactions
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Hepatobiliary events
|
9 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Malignancies (excluding lymphoma)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6 ~ Month 48 (every 6 months ± 6 weeks)Population: Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.
Efficacy was assessed by the evaluation of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI questionnaire consists of 6 component questions about the disease activity. For each question the possible answer from the patient is a whole number from 0 to 10 inclusive where 0 = None and 10 = Very severe. The BASDAI score is generated from the set of 6 questions and calculated using the following formula BASDAI = \[Q1+Q2+Q3+Q4+(\[Q5+Q6\]/2)\]/5. The number and percentage of patients achieving BASDAI 50 will be displayed. BASDAI 50 is defined as a 50% decrease of the baseline BASDAI score. Percentages will be calculated using the number of patients who perform the assessment at each time point.
Outcome measures
| Measure |
Remsima
n=98 Participants
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=20 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=3 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=4 Participants
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 6
|
60 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 12
|
35 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 18
|
16 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 24
|
13 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 30
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 36
|
12 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
The Number and Percentage of Patients Achieving BASDAI 50
Month 48
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 ~ Month 48 (every 6 months ± 6 weeks)Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.
The Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire consists of 10 component questions measuring functionality. Each item was given a rating by the patient which is a whole number from 0 to 10 inclusive where 0 = Easy and 10 = Impossible. The BASFI score is generated from the mean of the scores for the 10 items. The lowest score is 0 and the highest score is 10, with higher scores indicating a higher degree of functional limitation in patients.
Outcome measures
| Measure |
Remsima
n=98 Participants
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=20 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=3 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=4 Participants
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
Descriptive Statistics for BASFI
Day 0
|
4.10 score on a scale
Standard Deviation 2.684
|
1.35 score on a scale
Standard Deviation 1.746
|
2.07 score on a scale
Standard Deviation 3.239
|
1.65 score on a scale
Standard Deviation 2.014
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for BASFI
Month 6
|
1.38 score on a scale
Standard Deviation 1.498
|
1.10 score on a scale
Standard Deviation 1.614
|
0.70 score on a scale
Standard Deviation 1.212
|
1.93 score on a scale
Standard Deviation 1.427
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for BASFI
Month 12
|
1.36 score on a scale
Standard Deviation 1.553
|
1.43 score on a scale
Standard Deviation 1.679
|
3 score on a scale
|
3.05 score on a scale
Standard Deviation 1.061
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for BASFI
Month 18
|
1.38 score on a scale
Standard Deviation 1.774
|
1.70 score on a scale
Standard Deviation 2.121
|
2.40 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for BASFI
Month 24
|
1.29 score on a scale
Standard Deviation 1.854
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for BASFI
Month 30
|
1.23 score on a scale
Standard Deviation 1.347
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for BASFI
Month 36
|
1.46 score on a scale
Standard Deviation 1.864
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for BASFI
Month 48
|
1.28 score on a scale
Standard Deviation 2.274
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 ~ Month 48 (every 6 months ±6 weeks)Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.
Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity.
Outcome measures
| Measure |
Remsima
n=98 Participants
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=20 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=3 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=4 Participants
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of Physician Global Assessment Score
Day 0
|
54.3 score on a scale
Standard Deviation 28.09
|
20.0 score on a scale
Standard Deviation 17.17
|
30.0 score on a scale
Standard Deviation 14.14
|
22.5 score on a scale
Standard Deviation 18.93
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Physician Global Assessment Score
Month 6
|
16.5 score on a scale
Standard Deviation 17.19
|
13.1 score on a scale
Standard Deviation 7.93
|
6.7 score on a scale
Standard Deviation 11.55
|
20.0 score on a scale
Standard Deviation 14.14
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Physician Global Assessment Score
Month 12
|
15.6 score on a scale
Standard Deviation 16.80
|
11.4 score on a scale
Standard Deviation 3.63
|
30.0 score on a scale
|
5.0 score on a scale
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Physician Global Assessment Score
Month 18
|
7.8 score on a scale
Standard Deviation 8.93
|
30.0 score on a scale
Standard Deviation 14.14
|
40.0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Physician Global Assessment Score
Month 24
|
2.2 score on a scale
Standard Deviation 4.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Physician Global Assessment Score
Month 30
|
0.9 score on a scale
Standard Deviation 0.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Physician Global Assessment Score
Month 36
|
1.9 score on a scale
Standard Deviation 2.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Physician Global Assessment Score
Month 48
|
2.2 score on a scale
Standard Deviation 3.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 ~ Month 48 (every 6 months ±6 weeks)Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.
Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity.
Outcome measures
| Measure |
Remsima
n=98 Participants
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=20 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=3 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=4 Participants
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of Patient Global Assessment Score
Day 0
|
54.0 score on a scale
Standard Deviation 30.76
|
25.5 score on a scale
Standard Deviation 20.89
|
25.0 score on a scale
Standard Deviation 21.21
|
40.0 score on a scale
Standard Deviation 29.44
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Patient Global Assessment Score
Month 6
|
21.5 score on a scale
Standard Deviation 22.59
|
20.6 score on a scale
Standard Deviation 13.89
|
23.3 score on a scale
Standard Deviation 25.17
|
35.0 score on a scale
Standard Deviation 34.16
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Patient Global Assessment Score
Month 12
|
21.3 score on a scale
Standard Deviation 23.52
|
19.3 score on a scale
Standard Deviation 15.92
|
30.0 score on a scale
|
40.0 score on a scale
Standard Deviation 42.43
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Patient Global Assessment Score
Month 18
|
21.3 score on a scale
Standard Deviation 30.37
|
25.0 score on a scale
Standard Deviation 7.07
|
30.0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Patient Global Assessment Score
Month 24
|
3.1 score on a scale
Standard Deviation 4.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Patient Global Assessment Score
Month 30
|
2.1 score on a scale
Standard Deviation 1.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Patient Global Assessment Score
Month 36
|
2.6 score on a scale
Standard Deviation 2.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Patient Global Assessment Score
Month 48
|
2.8 score on a scale
Standard Deviation 3.60
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 ~ Month 48 (every 6 months ±6 weeks)Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. This study's primary objective is to compare RemsimaTM in patients with AS with patients receiving other anti-TNF drugs', especially with 'Remicade'. Therefore Switch to Remsima II" and "Switch to Other Anti-TNF" groups' are excluded from the results.
Patient Assessment of Spinal Pain will be measured by VAS (0-100 mm) for EU patients and NRS (0-10) for Korea patients where higher scores indicates more severe pain. Descriptive statistics for actual value of Spinal Pain Score will be summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS will be transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more pain as assessed by the patient.
Outcome measures
| Measure |
Remsima
n=98 Participants
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=20 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=3 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=4 Participants
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of Spinal Pain Score
Day 0
|
52.9 score on a scale
Standard Deviation 29.84
|
23.5 score on a scale
Standard Deviation 19.81
|
25.0 score on a scale
Standard Deviation 21.21
|
42.5 score on a scale
Standard Deviation 26.30
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Spinal Pain Score
Month 6
|
18.7 score on a scale
Standard Deviation 20.83
|
21.9 score on a scale
Standard Deviation 16.42
|
6.7 score on a scale
Standard Deviation 11.55
|
27.5 score on a scale
Standard Deviation 27.54
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Spinal Pain Score
Month 12
|
19.8 score on a scale
Standard Deviation 22.70
|
22.1 score on a scale
Standard Deviation 14.77
|
30.0 score on a scale
|
25.0 score on a scale
Standard Deviation 35.36
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Spinal Pain Score
Month 18
|
16.3 score on a scale
Standard Deviation 26.78
|
15.0 score on a scale
Standard Deviation 7.07
|
30.0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Spinal Pain Score
Month 24
|
3.1 score on a scale
Standard Deviation 4.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Spinal Pain Score
Month 30
|
2.0 score on a scale
Standard Deviation 1.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Spinal Pain Score
Month 36
|
2.4 score on a scale
Standard Deviation 2.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Spinal Pain Score
Month 48
|
2.7 score on a scale
Standard Deviation 3.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Remsima
Serious events: 14 serious events
Other events: 50 other events
Deaths: 1 deaths
Switch to Remsima I
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Switch to Remsima II
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Remicade
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Switch to Remicade I
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Switch to Remicade II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other Anti-TNF
Serious events: 11 serious events
Other events: 43 other events
Deaths: 0 deaths
Switch to Other Anti-TNF
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remsima
n=124 participants at risk
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=23 participants at risk
Patients who switched from Remicade to Remsima were included in this analysis group
|
Switch to Remsima II
n=10 participants at risk
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
n=3 participants at risk
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
n=5 participants at risk
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group.
|
Other Anti-TNF
n=146 participants at risk
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=18 participants at risk
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
General disorders
Pyrexia
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
General disorders
Sudden death
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Diverticulitis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Herpes zoster
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Influenza
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Pneumonia
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Pyelocystitis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Pyelonephritis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Pyelonephritis acute
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Tuberculosis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Psychiatric disorders
Depression
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
Other adverse events
| Measure |
Remsima
n=124 participants at risk
Patients who have received only Remsima were included in this analysis group
|
Switch to Remsima I
n=23 participants at risk
Patients who switched from Remicade to Remsima were included in this analysis group
|
Switch to Remsima II
n=10 participants at risk
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
n=3 participants at risk
Patients who have received only Remicade were included in this analysis group.
|
Switch to Remicade I
n=5 participants at risk
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group.
|
Other Anti-TNF
n=146 participants at risk
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=18 participants at risk
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Cardiac disorders
Palpitations
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Ear and labyrinth disorders
Vertigo
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
4/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
1.4%
2/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Gastrointestinal disorders
Nausea
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
General disorders
Chest pain
|
1.6%
2/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
20.0%
1/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Bronchitis
|
4.8%
6/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
12/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
8.2%
12/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Sinusitis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Tonsillitis
|
4.0%
5/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
1.4%
2/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
3/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
30.0%
3/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
2.1%
3/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
11.1%
2/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Investigations
Liver function test Increased
|
4.0%
5/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
3.4%
5/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
20.0%
1/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Nervous system disorders
Dizziness
|
1.6%
2/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
1.4%
2/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
1.4%
2/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
6/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
2.7%
4/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
2/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
2.7%
4/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.6%
2/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
20.0%
1/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
2.1%
3/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Vascular disorders
Hypertension
|
5.6%
7/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Ear and labyrinth disorders
OTORRHOEA
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Eye disorders
Uveitis
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
General disorders
Oedema peripheral
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Immune system disorders
Hypersensitivity
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
1.4%
2/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Pharyngitis
|
2.4%
3/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Investigations
Transminases increased
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Metabolism and nutrition disorders
Hyperlipideamia
|
0.81%
1/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
1.6%
2/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.68%
1/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Nervous system disorders
Headache
|
1.6%
2/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
5.6%
1/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/124 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
10.0%
1/10 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/5 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
—
0/0 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/146 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
0.00%
0/18 • Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place